Quality

Quality

Quality operations is an essential function of the life sciences industry. Drug manufacturers must thoroughly test materials, processes, equipment, techniques, environments and personnel in order to ensure their final products are consistent, safe, effective and predictable. Even when a drug does make it to market, there is no guarantee it will succeed.

From January 2013 to October 2018, approximately 8,000 medications were recalledby pharmaceutical companies globally, following concerns over quality. Whileevery year, €4.5bn is wasted due to expired, lost or uncaptured medical device charge costs. To avoid operational inefficiencies, information needs to be kept up-to-date and products captured at point of use to enable intelligent healthcare and purchasing decisions.

Companies are all too aware of the risk, according to research,67% of executivesconsider cost of quality essential to competitive success. Quality issues can be the result of a slip up somewhere along a complex supply chain or during the design, testing and manufacturing process. A single error can have severe consequences not just for patients, but shareholders too - one major quality event can mean a ten percent drop in a manufacturer’s share price, accordingto MGI.

One of the most recognised groups representing quality professionals in Germany is theGerman Quality Management Association(GQMA). The organisation is the largest German association for quality management in the chemical and pharmaceutical industry, and is led by itsPresident, Steffen König. Their aims include the promotion of scientific information and opinion exchange as well as the promotion of purpose-specific education and training.

One of the key areas GQMA must educate its members on is Industry 4.0. Ushering in a new era of interdisciplinary research and practice that focuses heavily on interconnectivity, automation, machine learning, and real-time data, Industry 4.0 has the potential to revolutionise the quality process.According to a report by Pharma Manufacturing, the first real-life cases of implementing such innovations have delivered a 50% reduction in overall quality control costs. Digitisation and automation will also ensure better quality and compliance by reducing manual errors and variability, as well as allowing faster and effective resolution of problems. Test cases have demonstrated incidents with over 90% faster closure times.

InDeloitte’s Global Life Sciences Sector Outlook,research points to “an evolving regulatory and risk environment” heightening the need for skilled life sciences professionals. As the life sciences industry continues to grow, so too will the medical device and pharmaceutical quality assurance sectors.

EPM Scientific is a global specialist recruitment company working exclusively in the Life Sciences industry. Our expert consultants place the best talent in the quality industry in Germany and across Europe.


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Quality Jobs

Head of Operational Quality Assurance

My client, an international contract manufacturer for Medical Device and Diagnostics, are looking for an experienced manager to join the team as Head of Operational Quality Assurance, reporting into the Head of Quality and Director of Global Quality - Medical. You and your team of QA specialists and quality inspectors will ensure that the quality specifications of medical devices are met and continually optimise processes and methods to increase the efficiency and effectiveness. You will also work closely with the other department leads to ensure quality processes are aligned across the business. Responsibilities: Coordination and organisation of incoming goods inspection processes. Maintaining clean-room qualification, including carrying out regular monitoring. Recording and processing deviations, changes and CAPAs Coordination and organisation of the batch release and conducting a documented batch record review Timely release or blocking of incoming goods, semi-finished goods and finished goods. Timely communication of deviations according to their importance. Personnel management of 7 employees. Requirements: Technical qualification/university degree and experience in a relevant field e.g. medical engineering Good knowledge of ISO 13485 / 14644 / 14971 IT tools (e.g. Office, SAP, QM tools) Excellent German and English language skills Previous management / leadership experience

Negotiable
Rapperswil-Jona
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Sr. Manager, Quality (Medical Device)

Title: Manager/Sr. Manager, Quality (Medial Device) Location: Billerica, MA A leading pharma/med device company is seeking a Manager/Sr. Manager to spearhead Quality activities related to their combination products. The Sr. Manager of Quality will be responsible for all aspects of QA for medical devices manufactured on site or through third party contractors. Responsibilities: Review and approved Device History Records Work on technical investigations relating to product complaints Oversight of vendor/supplier management program - change notifications, audit schedule, status tracking, etc. Ensure site inspection readiness for both internal and external audits Qualifications: Bachelors degree with approx. 8-10 years of Quality experience in medical device, combination product experience preferred Direct experience with medical device complaints investigations and inspection readiness Experience working directly with FDA/notified bodies Must be authorized to work in the united states without sponsorship If you are curious to hear more, please don't hesitate to apply!

Negotiable
Billerica
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Quality Control Manager

Quality Control Manager Location: Miami, Florida Work Situation: Hybrid Level: Manager A global pharmaceutical company specializing in oncology products is seeking an experienced and dedicated Quality Control Manager to join their site in Miami, Florida. The QC Manager will be part of a dynamic team dedicated to ensuring our products' safety, efficacy, and quality. With cutting-edge facilities, rigorous quality standards, and a commitment to excellence, we offer an exciting opportunity to make a meaningful impact on global health. Join us in shaping the future of cancer treatment and improving patient outcomes worldwide. The Quality Control Manager will be responsible for: - Lead and develop a team overseeing all QC operations, including Chemistry and Microbiology Laboratories - Manage lab operations, Quality Record management, LIMS administration, and Stability Program - Implement internal KPIs for Safety, Quality, Operational Effectiveness, and Training - Provide expertise on chemistry and microbiology strategy, procedures, and regulatory compliance - Lead internal projects for formulation, filling, and facility improvements - Perform administrative duties associated with managing a department and staff - Identify and address quality issues, recommending corrective actions The Quality Control Manager will have the following qualifications: - BA/BS in Chemistry, Biology, Microbiology, or Life Sciences - 8 years of pharmaceutical experience, including laboratory management - 2+ years of management-level experience - 2+ years of experience in oncology products - Thorough knowledge of cGMPs, GLPs, and pharmaceutical manufacturing - Proficiency in auditing, root cause analysis, problem-solving, and decision-making - Six Sigma Greenbelt certification, preferred If you are interested in becoming a Quality Control Manager, apply now!

US$100001 - US$130000 per annum
Miami
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Quality Control Manager

Quality Control Manager Location: Omaha, Nebraska Working Situation: Onsite Level: Mid-Senior Level We are seeking a dedicate Quality Control Manager to oversee Quality Control projects within our manufacturing site. This role involves managing various activities such as product transfers, automation, and assay enhancements. Working in a dynamic manufacturing environment, you will play a pivotal role in ensuring the efficient execution of testing protocols to supply animal health products. The Quality Control Manager will be responsible for: Provide leadership, coaching, and mentorship to a team of 3-4 QC professionals Demonstrate knowledge of final and bulk product testing, raw materials, and analytical techniques essential for supporting manufacturing processes Take ownership of authoring, reviewing, revising, and approving SOPs, Quality Control Procedures, and other essential documentation, including change management oversight Conduct thorough evaluation of generated data, monitor trends in routine assays, and recommend improvements or alternative strategies Lead or support investigations, Root Cause Analysis, and CAPA implementation and effectiveness evaluations Promote a culture of safety and compliance throughout the laboratories. Serve as a liaison between operations, technicians, and support groups to advocate for laboratory needs and ensure alignment with broader organizational goals Collaborate closely with Quality Assurance and Operations colleagues to address quality-related challenges and optimize processes The Quality Control Manager will have the following qualifications: Bachelor's degree in Biology, Microbiology, Chemistry, or a related field. Minimum of five (5) years of experience in Quality Control procedures and technical development within a cGMP environment Minimum of three (3) years of experience in people leadership, leading teams of 2 or more Familiar with Continuous Improvement, Lean Six Sigma, and/or Lean methodologies, preferred Prior experience with automation, preferred If you are interested in joining our team as the Quality Control Manager, apply now!

US$95000 - US$115000 per annum
Omaha
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Validation Lead

Validation Lead Location: Raleigh, NC Working Situation: Hybrid A global speciality pharmaceutical company is looking to bring on a Validation Lead to support the global quality organization. You will be supporting tech transfer and validation activities while also working cross-functionally to support all GxP related issues at the Raleigh, NC site. The Validation Lead will be responsible for: Develop and implement comprehensive validation strategies for sterile manufacturing processes, equipment, and systems to ensure compliance with regulatory requirements (e.g., FDA, EMA, etc.) and industry standards. Lead the creation, review, and approval of validation protocols and reports, including but not limited to process validation, equipment qualification, cleaning validation, and computer system validation. Collaborate closely with cross-functional teams, including Manufacturing, Quality Assurance, Regulatory Affairs, Engineering, and R&D, to resolve all GxP related issues effectively including discrepancy investigations, CAPAs, change controls, key process development activities, and continuous improvement process reports. Oversight of all GMP Compliance and Operational QA (Quality Assurance) aspects of Product. Provides insight into the creation, revision, review, and approval of validation protocols. The Validation Lead will have the following qualifications: Bachelor's degree in a Science, Engineering or related field Minimum 5 years of experience in validation within the pharmaceutical industry, with specific expertise in sterile manufacturing processes and regulatory requirements. Experience necessary with pharmaceutical process validation, cleaning validation, equipment, utilities, and computer system qualification processes. Ability to work independently and as part of a team. If you are interested in the role of Validation Lead, don't hesitate to apply today!

US$110000 - US$125000 per annum
Raleigh
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Quality Control Manager

Quality Control Manager Location: Raleigh, NC Working situation: Onsite Level: Manager Company Summary: Our client, a mid-sized pharmaceutical company, specializing in injectable products, is currently seeking a driven, motivated, and multi-faceted Quality Control Manager. This role will be located in the greater RTP, NC area. The Quality Control Manager will play a critical role in ensuring the quality and compliance of biologics products through the development, implementation, and oversight of quality control systems and processes. The Quality Control Manager will be responsible for: Develop, implement, and maintain robust quality control systems to ensure compliance with regulatory requirements and industry standards (including FDA regulations and cGMP guidelines). Oversee all aspects of quality control activities related to biologics biopharmaceutical manufacturing, including raw materials testing, in-process testing, and finished product testing. Establish and maintain appropriate quality control documentation, including standard operating procedures (SOPs), protocols, and reports. Provide leadership and guidance to the quality control laboratory team, ensuring that testing activities are conducted accurately, efficiently, and in accordance with established procedures. Lead investigations into deviations, out-of-specification results, and non-conformances, implementing corrective and preventive actions as necessary. Provide quality control expertise and guidance to cross-functional teams, ensuring alignment with quality objectives and regulatory requirements. The Quality Control Manager has the following qualifications: Bachelors degree in a relevant scientific discipline (e.g., biology, chemistry, microbiology) required; advanced degree preferred. 6+ years of QC experience in pharmaceutical, biotechnical, or medical device environments. 4+ years of QC supervisory experience. Thorough knowledge of cGMPs, GLPs, and pharmaceutical manufacturing Benefits: Health, vision, and dental benefits Annual holiday bonus Dynamic, fast-paced, and collaborative work environment If you see yourself in this Quality Control Manager role and are interested, then please don't wait to apply.

Negotiable
Raleigh
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Quality Technician III

Summary: A leading contract manufacturing firm headquartered in Minneapolis, MN, is seeking a Quality Technician III to join its team. In this role, you will play a pivotal part in fostering a Culture of Quality and Continuous Improvement throughout the organization by encouraging compliance with Quality System standards across all departments. The company, known for its innovative contributions to medical contract manufacturing and its expertise in intricate materials transformation for critical components utilized in diagnostics, wearable technologies, and electronic devices, is specifically interested in candidates with the following qualifications: Knowledge/Experience Needed: Collaborates with Customer Focused Teams and Production Focused Teams to develop and implement inspection test methods, programs, and relevant documentation. Supports Test Method Validation for inspections according to established protocols. Capable of effective communication across all levels of the organization, with customers, and with suppliers. Demonstrates autonomy and leadership within and beyond the Quality Group, requiring minimal oversight. Utilizes a risk-based approach to decision-making aligned with organizational objectives and customer performance targets. Actively participates in process improvement initiatives to enhance customer satisfaction. Adheres to all Quality System requirements and company procedures, ensuring ethical compliance with regulatory standards. Delivers on commitments punctually, with a keen focus on accuracy and attention to detail. Maintains up-to-date knowledge of relevant medical device regulations such as FDA QSR, ISO 13485, and ISO 14971, as well as other applicable standards and guidance documents. Proficiently sets up, adjusts, aligns, and operates advanced inspection equipment, including Coordinate Measuring Machines (CMM). Possesses extensive expertise in dimensional metrology and GD&T, with the ability to interpret blueprints effectively. Understands the importance of critical to quality requirements and is capable of assessing associated risks. Qualifications: A bachelor's degree in a scientific, engineering, or technical field. A genuine interest and commitment to process improvement. Understanding of GD&T principles Quality Technician Experience: at least 2 years' experience as a QTII, or Associates Degree in a related field, and at least 2 years' experience in a manufacturing environment including knowledge of CMM programming Vision correctable to 20/20 with normal color vision (where inspection criteria require color discernment) Technical program certification (e.g. ASQ-CQT) or an Associates Degree in Quality Technology preferred Proficient with Microsoft Office software and familiar with CMM program execution and programming and GD&T software (SmartProfile, Measure-Fit) Benefits: Full-time employees become eligible for benefits on the first of the month following 30 days of continuous service. These benefits include: Medical Insurance Dental Insurance Vision Insurance Employer-Paid Basic Life Insurance Supplemental Life Insurance Employer-Paid Short-Term Disability Long-Term Disability 401(k) Plan Paid Time Off Paid Holidays

US$65000 - US$80000 per year
Minneapolis
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Senior Quality Engineer

Summary: A reputable contract manufacturing firm based in Minneapolis, MN, is in search of a Senior Quality Engineer specialized in Production. This role involves cultivating a culture of Quality and Continuous Improvement throughout the organization by ensuring adherence to Quality System standards. The company, known for its innovative approach to medical contract manufacturing and expertise in intricate materials transformation for essential components used in diagnostics, wearable technologies, and electronic devices, is specifically seeking candidates with the following qualifications: Author, manage, and execute manufacturing process characterizations and validations (OQ and PQ), explaining their purpose and differences while describing sampling rationale for each. Lead Process Failure Modes and Effects Analyses (PFMEA) generation, adhering to PFMEA requirements and ISO 14971 standards. Conduct CAPA Investigations, proficient in all phases, tools, and methods, with a track record of successful implementations. Apply statistical methods in Quality Engineering, including Statistical Process Control (SPC) and process capability analysis, ensuring risk-based approaches. Perform Test Method Validation and Measurement System Analysis (MSA), addressing GR&R failures and sustaining capability. Address non-normal variables data appropriately and apply Design of Experiments (DOE) when needed. Utilize statistical software (e.g., JMP, Minitab) for Quality Engineering tasks. Define Quality personally and demonstrate understanding of FDA 21CFR820 and ISO 13485 requirements in Quality Engineering. Develop and implement Quality Control Plans, with practical examples of implementation. Engage with production personnel to support and foster a culture of quality and compliance, resolving challenges and driving sustainable improvements. Navigate ambiguity and make tough decisions to ensure customer requirements are met, drawing from experience in difficult situations. Qualifications: A bachelor's degree in a scientific, engineering, or technical field. A genuine interest and commitment to process improvement. 7+ years of experience, including at least 3 years at the senior level, in the medical device or related manufacturing industries, with direct experience relevant to the job responsibilities. Proficiency in statistical techniques, data management, investigation techniques, and technical writing. Six Sigma Green Belt (or higher) certification is highly desirable. Benefits Offered: Medical Insurance Dental Insurance Vision Insurance Employer-Paid Basic Life Insurance Supplemental Life Insurance Employer-Paid Short-Term Disability Long-Term Disability 401(k) Plan Paid Time Off Paid Holidays

US$86000 - US$120000 per year
Minneapolis
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Senior Manager/ Associate Director QA (GLP/GCP)

Overview: QA Leader to support the quality management systems and processes for a CRO based in Burlington. Working within pharma in both biologic development and cell and gene therapy and reporting directly to the Senior Director of Global Compliance. Role Responsibilities: Shape and expand our US quality management systems. Lead audits, ensuring GCP/GLP compliance. Oversee systems, suppliers, and employee training. Drive continuous improvement in quality processes. Champion a strong quality culture within the team. Collaborate with clients, auditors, and internal teams. Previous Experience: 5+ years QA GCP/GLP experience (biopharma/cell & gene therapy a plus) Passion for quality and cultural change leadership Regulatory auditing experience Excellent communication, teamwork, and leadership skills Experience leading/participating in regulatory GCP/GLP audits

Negotiable
Burlington
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Quality Control Specialist

Quality Control Specialist Pay Rate: $35-$40/hour Our client is a commercial-stage biopharmaceutical company focused on the research, development, and commercialization of innovative immunotherapies to treat cancer and the commercialization of their portfolio of FDA-approved therapeutics. We are building a leading oncology company backed by in-house expertise and an established infrastructure from our diversified portfolio of FDA-approved biosimilar products. Our client is in need of a Quality Control Specialist (hybrid role on a 6 month contract) to assist the team in developing innovative immuno-oncology therapies while maintaining its dedication to the patients and the team's track record of success in research, development, and manufacturing. Qualification for the role: Manufacturing and Commercial experience Experience with doing a lot of QC systems produce compliance check within that on-site lab environment Strong understanding lab investigations CAPA investigation hands on QC operations 2 to 3 years GMP experience in pharma and biopharma Any vendor experience would be preferred but not required Experience with deviation, CAPA, change control Any experience with helping GMP auditing with vendors

US$35 - US$40 per hour
United States of America
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Technical Writer

Technical Writer A Mid-Size Pharmaceutical Manufacturing company is seeking a skilled and detail-oriented Technical Writer to join their team. The ideal candidate will have a strong background in scientific writing and a thorough understanding of pharmaceutical regulations and documentation requirements. As a Pharmaceutical Technical Writer, you will collaborate closely with cross-functional teams to create, revise, and maintain a wide range of technical documents critical to the development, production, and regulatory compliance of pharmaceutical products. The Technical Writer will have the following responsibilities... Documentation Creation: Develop and maintain comprehensive technical documents including, but not limited to, standard operating procedures (SOPs), batch records, validation protocols and reports, regulatory submissions, and quality assurance documents. Regulatory Compliance: Ensure all documentation complies with relevant regulatory requirements such as FDA guidelines, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and International Council for Harmonisation (ICH) guidelines. Collaboration: Work closely with subject matter experts, scientists, engineers, regulatory affairs professionals, and other stakeholders to gather information and ensure accuracy and completeness of technical documentation. Review and Revision: Review existing documents for accuracy, clarity, and compliance with internal standards and regulatory requirements. Update and revise documents as necessary to reflect changes in processes, procedures, or regulations. Process Improvement: Identify opportunities for process improvements in documentation creation, management, and distribution. Implement best practices to enhance efficiency and effectiveness in documentation processes. Training Support: Provide support for training programs by developing training materials, presentations, and manuals to ensure understanding and compliance with documented procedures and protocols. The Technical Writer should have the following qualifications... Bachelor's degree in pharmacy, pharmaceutical sciences, life sciences, chemistry, or a related field. Proven experience (3 years) in technical writing within the pharmaceutical industry, preferably in a regulated environment. Strong knowledge of pharmaceutical regulations and guidelines, including FDA regulations, GMP, GCP, and ICH guidelines. Excellent writing, editing, and proofreading skills with a keen attention to detail. Proficiency in Microsoft Office Suite and document management systems. Ability to work independently and collaboratively in a fast-paced environment with changing priorities. Excellent communication and interpersonal skills, with the ability to effectively interact with cross-functional teams and stakeholders. Benefits: Competitive Salary Health, dental and vision insurance 401k match If you are interested in the position of Technical Writer, please don't hesitate to apply!

Negotiable
Kansas City
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Microbiology Manager

Microbiology Manager Location: Kansas City Working Situation: On-site A mid-size Pharmaceutical company is seeking a dynamic and experienced Microbiology Manager to lead our microbiology department. The Microbiology Manager will be responsible for overseeing all aspects of microbiological testing, research, and analysis to ensure compliance with regulatory standards and support product development and quality assurance efforts. The ideal candidate will have a strong background in microbiology, proven leadership skills, and the ability to effectively manage a team in a fast-paced environment. The Microbiology Manager will have the following responsibilities... Lead and manage the microbiology department, including hiring, training, and supervising staff members. Develop and implement microbiological testing protocols and procedures to ensure accurate and reliable results. Oversee the execution of microbiological tests, including microbial identification, enumeration, and susceptibility testing. Coordinate with other departments to ensure timely and efficient testing of raw materials, in-process samples, and finished products. Review and analyze microbiological data to identify trends, deviations, and areas for improvement. Ensure compliance with regulatory requirements, including FDA, ISO, and other relevant standards. Drive continuous improvement initiatives to enhance efficiency, quality, and productivity within the microbiology department. Maintain a safe and clean laboratory environment and ensure adherence to health and safety protocols. The Microbiology Manager should have the following qualifications... Bachelor's degree in Microbiology, Biology, or related field; Master's or Ph.D. preferred. Minimum of 15 years of experience in a microbiology laboratory, with 5 years in a supervisory or managerial role. Strong knowledge of microbiological principles, techniques, and methodologies. Experience with a variety of microbiological testing methods, including but not limited to culture-based, molecular, and biochemical techniques. Familiarity with regulatory requirements and quality standards for microbiological testing (e.g., FDA, ISO, USP). Excellent leadership, communication, and interpersonal skills. Proven ability to effectively manage projects, prioritize tasks, and meet deadlines. Detail-oriented with strong analytical and problem-solving abilities. Ability to work collaboratively in a cross-functional team environment. Benefits: Competitive salary Medical, Dental and Vision Insurance 401k Match If you are interested in the Microbiology Manager, please don't hesitate to apply!

US$100000 - US$120000 per annum
Kansas City
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