Site Quality Head
Greater Boston Area
Have you ever wanted to join a company where you have the resources of a large company, and yet it is still small enough to provide you with the opportunity for advancement? Our client is a medium sized sterile pharmaceutical manufacture that will be able to provide you with this balance. This position will be based at the company's state of the art manufacturing facility that will allow you to oversee the quality of all the newest aseptic filling technology in the industry. If you are looking for you next opportunity to oversee all of quality for a single site, with fantastic long-term career growth than don't hesitate to apply!
The Site Quality Head will have the following responsibilities:
- Ensure that the global quality policy is understood, implemented, and maintained at all levels of the organization
- Ensure that products are designed and produced in accordance with the requirements of the QMS
- Provide input into the design, development, construction and establishment of a new manufacturing facility housing state of the art isolator filling line
- Routinely assesses optimal organizational structure and resource requirements to assure compliant performance and timely completion of priorities
- Evaluate, recommend and implement improvement strategies to company Quality Systems to ensure that Quality Requirements are consistent with Current Guidelines and Industry Standards
- Actively interact with and influences the development and formalization of corporate laboratory control standards, policies and guidelines
- Actively develop strategies and actions to continuously improve data management practices and test method reliability assuring continual inspection readiness and on time release expectations
- Work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors, root cause analysis and risk assessments
- Provide leadership and direction to the Compliance team focusing on development of the skills and effectiveness of the group
- Partner with Business Development to create billable contract services related to Quality function
- Lead and direct the work of others and relies on extensive experience and judgment to plan and accomplish goals
The ideal candidate will have the following skill set:
- Strong Leadership Background (ideally have held a Site Quality Head position previously)
- Strong Quality Operations background
- Proven ability to succeed in cGMP environment
- Hands on experience with sterile manufacturing.
- Experience in QA/QC
- Experience building Quality Systems