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, โ‚ฌ4.5bn 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 manufacturerโ€™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 Kรถnig. 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.

InDeloitteโ€™s Global Life Sciences Sector Outlook,research points to โ€œan evolving regulatory and risk environmentโ€ 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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Benefits of working with us

Experience

We have over a decadeโ€™s worth of experience as a leading talent partner in Life Sciences & Pharma.

Network

A vast, global network of the best, in-demand professionals, working with the worldโ€™s largest Life Sciences institutions, to take drugs, devices and therapeutic applications through from conception to completion.

Knowledge

Our award-winning talent specialists offer bespoke, tailored guidance on the latest hiring trends and industry news to help you achieve your goals.

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Quality Jobs

Quality Systems Engineer

Summary: As the Quality Systems Engineer, you will ensure the implementation, maintenance, monitoring, and reporting of designated quality system processes to ensure their sufficiency and continual enhancement in an ISO13485 environment. With a primary focus on nonconformance and Corrective and Preventive Action (CAPA) quality systems, this role spearheads and assists in investigations, root cause analyses, corrective actions, and the management of nonconformance and CAPA processes. The ideal candidate possesses a robust background in quality systems, adept problem-solving abilities, and a steadfast commitment to upholding quality standards within the medical device industry. Key Responsibilities: Standardize process and reporting protocols to accurately document nonconformances, CAPAs, and associated corrective actions in compliance with regulatory directives within the medical device industry. Supervise, gather, and analyze quality data, and furnish reports on external and internal audit observations and the status of corrective actions. Collaborate with assigned business lines to conduct inquiries into product quality issues, deviations, out-of-specification occurrences, and nonconformances, ensuring swift and effective resolutions. Develop training materials and resources to enable staff to employ root cause analysis methodologies (such as 6M, Fishbone, 5 Whys, etc.) to identify underlying factors contributing to nonconformances. Create and execute CAPAs to address identified root causes and prevent the recurrence of nonconformances, ensuring clear definition, timely execution, and effective tracking to completion. Compile and deliver reports summarizing investigation findings, root causes, corrective actions, and outcomes to management and relevant stakeholders. Collaborate with cross-functional teams, including Quality, Regulatory, Operations, R&D, etc., to implement process enhancements based on analyses from nonconformance investigations. Monitor the efficacy of implemented corrective actions, utilizing key performance indicators to assess progress and drive continual improvement. Stay abreast of pertinent quality standards, regulatory requirements, and industry best practices related to nonconformance and CAPA processes. Responsible for overseeing and reporting on quality data in other designated quality system processes, as assigned. Qualifications: Education and Experience: Bachelor's Degree in Life Sciences or a related technical discipline (e.g., biomedical engineering) or field. Minimum of 5 years of experience in an ISO 13485 environment. At least 3 years of direct experience in nonconformance and CAPA investigation within the medical device industry. Previous experience supporting and facilitating internal and external audits within the medical device field. Certificates, Licenses, Registrations: Certification as a quality auditor or similar industry certification. Benefits: Full-time team members become eligible for benefits starting the first day of the month following 30 days of employment. These include: Health Insurance: High Deductible Health Plan (HDHP) with Health Savings Account (HSA) - with an employer contribution of $1,040 annually. High Preferred Provider Organization (PPO) Low Preferred Provider Organization (PPO) Flexible Spending Account (FSA) Dental Insurance Vision Insurance Basic Life Insurance (Employer-paid) Supplemental Life Insurance Short-term Disability Insurance (Employer-paid) Long-term Disability Insurance 401(k) Plan with a 4% Employer Match Paid Time Off (accrued at 120 hours per year)* 9 Paid Holidays Access to Continuing Education and Seminar Programs Employee Assistance Program (EAP) Fitness Room Access

US$100000 - US$110000 per year
Minneapolis
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Senior Quality Assurance Manager

Senior Quality Assurance Manager Location: Atlanta, GA Working Situation: Remote Level: Senior Level We are currently seeking a talented and experienced Senior Quality Assurance Manager to join our team in Atlanta, GA. We are a global biotechnology company focusing on human and animal tissues, cell products, and other biofluids. This permanent position offers an exciting opportunity for a Quality Assurance professional with expertise in Good Clinical Practice (GCP), Good Manufacturing Practice (GMP/cGMP) and auditing. As the Senior Quality Assurance Manager, you will be responsible for ensuring compliance with GCP, GMP and maintaining a Quality culture while developing and implementing training programs, conducting audits and inspections, compiling detailed reports, and supervising staff. The Senior Quality Assurance Manager will: Lead GCP/GMP trainings, ensure compliance, and update relevant parties Compile audit findings, review responses, and follow up Review System Validation protocols and maintain QA records Develop QA auditing procedures and SOPs, manage scheduling Serve as liaison for client and regulatory inspections, communicate with stakeholders Conduct internal and external audits, and ensure policy adherence for all regulatory bodies Supervise staff, including training, assigning work, conducting appraisals, and providing feedback The Senior Quality Assurance Manager will have the following qualifications: Bachelor's Degree in relevant field, Biology or Chemistry preferred 9+ years of relevant industry experience 4+ years leading a team ASQ certification, preferred If you're interested in joining our team as the Senior Quality Assurance Manager, apply now!

US$150000 - US$180000 per annum
Atlanta
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Sr. QA Specialist

Sr. QA Specialist Position ($95K-$105K/year) This company is a pioneer in the cGMP production sector and is committed to developing gene therapy. Their goal is to create novel, secure, and efficient long-term treatments for illnesses by utilizing their expertise, resources, technology, and knowledge in the fields of translational and regulatory science. As they work to make a difference with every product and instill hope in the hearts of every patient and their family, there is no condition too uncommon or difficulty too great. The main idea of this biotech company is the full-service production of Adeno Associated Viruses (AAV). Every year, they collaborate with more than 100 clients to produce AAV at levels of development, toxicological, clinical, and commercial grade. Duties and Responsibilities: Scheduling, preparing, and performing internal and external audits support of GMP Assembling and coordinating the activities of the audit team, if needed. Performing audits in accordance with the company's standard operating procedures, quality policies, GMP regulations. Escalating compliance issues, as needed. Communicating audit results to management and auditees through written audit reports. Leading post-audit activities, following up on vital corrective and preventive actions by resolving any issues. Assisting with hosting facility inspections by acting as ascribe and/or document reviewer, as needed. Drafting and issuing periodic reports to site management, as requested. Assignment, tracking and completion of CAPA activities associated with audits. Assisting with training/orientation for new Quality Auditing staff. Knowledge, Skills, and Abilities Required BA with at least three years of related experience in Biotech/Pharmaceutical industry At least three years of audit experience in a GMP environment preferred. Detailed oriented; ability to track timelines and milestones. Negotiation skills and ability to communicate with all levels of an organization. Proficiency in developing and writing procedures, audit reports and corrective action plans. Experience in using Track wise is preferred. Ability to work with minimal supervision.

US$95000 - US$105000 per year
Columbus
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Senior Quality Control Chemist

Senior Quality Control Chemist - 5 days on-site A small, well-established CDMO in Irvine, CA, wants to add a Senior QC Chemist to their team. Join this team to expand on your analytical experience in a cGMP environment. The organization supports its employees' growth and development, helping employees succeed in the pharmaceutical industry while supporting their network of clients. Currently, the team is only considering candidates local to Irvine, CA, or candidates who have a sustainable commute to their labs. Day to day: Analytical testing of raw materials, in-process samples, and final products Predominately utilize analytical instrumentation, and ensure proper functioning Carry out the development of analytical methods, and author SOPs Provide peer review for other technician's data Maintain and troubleshoot HPLC and other analytical instrumentation, and maintain equipment calibration and qualification Support management with training of team members, laboratory investigations, and internal/external audits Experience: Bachelor of Science in Chemistry or related field 8+ years of experience in the pharmaceutical/biotech environment Exposure to working with small molecules Experience working with HPLC, GC, CE, ICP, FTIR, and dissolution apparatus.

US$80000 - US$90000 per year + Medical, Dental, and Vision Insurance
Irvine
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CNC Operator

Rรดle: Opรฉrateur CNC Localisation: Suisse (Peut dรฉmรฉnager des personnes de France ou de Belgique) Permanent Une entreprise manufacturiรจre leader est actuellement ร  la recherche de plusieurs opรฉrateurs CNC pour rejoindre son รฉquipe. C'est l'occasion d'avoir un impact et de faire partie d'une incroyable culture d'รฉquipe. Responsabilitรฉs: Prรฉparer le dรฉmarrage de la machine Utiliser des machines CNC Responsable de la sรฉcuritรฉ et de l'hygiรจne Travailler en รฉquipe Signaler toute modification ou dysfonctionnement Exigences: Mรฉcanicien, dรฉcolleteur ou technicien en dรฉcolletage, ou niveau รฉquivalent. 3+ ans d'expรฉrience en usinage Comprendre l'utilisation des commandes CNC Ce rรดle sera un travail postรฉ Expรฉrience dans l'utilisation d'appareils de mesure et d'outils de coupe Langues : Franรงais

Negotiable
Switzerland
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Risk Manager

EPM is currently partnered with one of the leading Medical Device Manufacturers of intelligent ventilators who is seeking a Risk Manager to join their team Responsibilities: Planning and implementing the risk management process throughout the entire life cycle of the devices and accessories in accordance with relevant standards. Monitoring compliance with risk management processes and standards, ensuring adherence to internal processes and conducting compliant risk assessments. Serving as the primary point of contact for inquiries related to the risk management process. Providing support for internal and external audits, product approvals, and communication with regulatory authorities and partners. Contributing to the ongoing development and training of the risk management process. Qualifications: A university degree in engineering or relevant experience in a related technical field. Proficiency with international standards such as ISO 13485 and ISO 14971, as well as familiarity with medical device regulations like MDR 2017/745 and 21 CFR 820. Fluency in German and business-level proficiency in English (Level C1).

Negotiable
Switzerland
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Supplier Quality Management Engineer

Responsibilities: Assist the strategic sourcing team in reviewing, negotiating and reformulating existing quality agreements with suppliers Support in the creation of new quality agreements with new or existing suppliers Supporting the strategic procurement team in supplier audits You act as a link between the operational procurement team and suppliers You will act as a subject matter expert for all related supplier quality procedures and ensure compliance with relevant procedures Supporting production in case of supplier problems Creation of inspection plans for incoming goods Supporting Quality Engineers in reviewing and approving the test strategy, test plans and test reports in the implementation of product and process changes and their verifications Supporting Quality Engineers in ensuring the regulatory conformity of processes and products within the framework of quality assurance, taking into account the quality methods according to ISO 13485 and 21 CFR Parts 11 and 820 Requirements: Scientific or technical studies (e.g. mechanical engineering, electrical engineering, materials science, physics, process engineering, etc.) Experience in the field of quality assurance and compliance with regulations and quality standards of the medical device industry (21 CFR Part 11 and 820, Regulation (EU) 2017/745, ISO 13485, ISO 14971, ISO 9001) Experience in the field of risk management, ideally in medical technology Confident appearance and enjoyment in moderating discussions Fluent in German and English or willingness to learn them independently Basic knowledge of the use of Jira & Confluence is an advantage

Negotiable
Switzerland
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Supplier Quality Management Engineer

We have a current opportunity for a Supplier Quality Management Engineer on a permanent basis. The position will be based in Bonaduz. For further information about this position please apply.

Negotiable
Switzerland
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Associate Director Clinical GCP Quality

Our client is an industry-leading biotechnology company that specializes in developing groundbreaking cancer therapies that harness the power of cutting-edge technologies. They are currently seeking a highly experienced professional to join their team as the Associate Director of Clinical (GCP) Quality. Responsibilities: Proven track record in effectively managing and supervising CAPA plans, including writing, reviewing, approving, and closing them. Demonstrated capability in conducting and overseeing site, internal GCP, and vendor audits, along with directing and guiding audit follow-up actions. Proficiency in establishing Quality and Cross-Functional Standard Operating Procedures (SOPs) and processes, along with implementing associated document controls. Experience serving as a global document management system administrator. Skilled in managing and mentoring direct reports. Ability to coordinate cross-functional meetings between departments and Quality teams. Willingness to undertake other duties as assigned. Qualifications: Bachelor's degree or higher qualification within life sciences At least 10 years' experience working in GCP Quality Assurance and/or GCP Compliance, additional GCP Auditing experience preferred In-depth knowledge of global regulations related to good clinical practice Excellent interpersonal communication skills along with proficiency communicating both verbally and written formats. Bilingual Willingness to travel If you are interested, please apply with your CV attached.

Negotiable
Tokyo
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Director of Quality

Director of Quality - Med Device Location: Raleigh, NC Working situation: Hybrid Level: Director Our client, a large, successful med device company and is looking to add to their Quality team! The Director - Quality Assurance will help lead the Quality department and oversee all aspects of Quality Assurance. This individual will work to foster a culture of quality through providing leadership and guidance to their team and company. The Director - Quality Assurance will: Establish and maintain quality management systems (QMS) in accordance with ISO 13485 and other relevant standards. Identify, direct, and monitoring FDA and ISO audits, both internal and external, and assist with supplier audits Manage and mentor Quality management staff to promote personnel development and succession planning. Responsible for reviewing and delivering Quality Budget Collaborate cross-functionally with R&D, manufacturing, clinical affairs, and other departments to support product development, manufacturing, and commercialization activities. Drive a culture of quality and regulatory compliance throughout the organization, promoting awareness and understanding of quality and regulatory requirements among all employees. The Director - Quality Assurance has the following qualifications: Bachelor's Degree in Biology, Chemistry, Engineering, or related fields Minimum of 10 years of Quality experience in the Med Device industry 7-10 years of management experience In-depth knowledge of relevant regulations and standards, including FDA QSR, ISO 13485, MDR, and other global regulatory requirements. Strong leadership and management skills, with the ability to inspire and motivate teams to achieve results. Company Benefits: Competitive 401K program, health insurance, and HSA accounts Long term incentives in the terms of equity or stock at this level Flexible hybrid working model

Negotiable
Atlanta
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Quality Systems Manager

Quality Systems Manager As the Quality Systems Manager, you will play a pivotal role in championing daily activities for quality excellence. You will develop, implement, and enforce quality systems that meet the highest standards, including FDA Drug and Medical Device regulations, customer requirements, and internal business needs. Here's how you'll make a difference: Oversee and streamline deviation/non-conformance investigations and processes. Lead the Customer Complaint process, including trending, reporting, and investigations. Manage the Product Release Program, batch record review process, metrics, and customer CofAs. Spearhead Annual Product Reviews and Quarterly Management Reviews. Ensure quality and compliance by supervising the Document Control program, including change control and metrics. Develop and maintain quality documents related to job accountabilities. Manage the Internal Auditing program, including training, system development, and metrics. Partner with QA operations, QA lab, and manufacturing operations to develop and maintain quality systems and processes. Represent the company in regulatory inspections, customer audits, and third-party audits. Manage Cost of Quality. Develop and mentor your direct reports. Are you the right fit? Hold a bachelor's degree in a relevant field (chemistry, microbiology, biology, engineering, etc.) with an advanced degree a plus. Possess at least 7 years of experience in FDA-regulated quality assurance systems in manufacturing, including 3+ years in a leadership role. Have 5+ years of experience interacting with regulatory bodies (FDA, TGA). Be proficient in quality control methods like root cause analysis, risk analysis, and document control.

Negotiable
Morristown
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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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