Quality Assurance Senior Manager, QMS 1080445
Job Scope & Purpose:
Our Greater Boston area partner is an exciting biologics CDMO who has just built a state of the art facility and is in search of an exceptional QA professional to join their growing team. This global team based in the US and Europe is well-versed in all aspects of the biopharmaceutical value chain, from cell line development to commercial production and aseptic fill-finish. They are deeply invested in providing high quality CDMO services and long-term partnerships based on their blend of experience and openly collaborative project teams. If you have strong experience in QMS Migration and Master Control and are hungry to make an immediate impact with a growing team , consider applying now!
Primary Job Responsibilities:
- Plan, and direct quality control program designed for continuous production of products consistent with established standards.
- Develop and analyze statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished biologics product.
- Maintain quality control objectives and coordinate objectives with production procedures in cooperation with other plant managers to maximize product reliability and minimize costs.
- Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
- Develop quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
- Validate quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
- Maintain and improve product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
- Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
- Responsible for ensuring a product or service meets the established standards of quality including reliability, usability and performance required for distribution and the market.
Primary Job Requirements:
- Minimum of Bachelor's degree in a scientific discipline.
- 5 - 10 years industry QA experience including managing GXP quality systems in the Pharma/Biotech industry.
- Extensive knowledge of cGMP and ICH requirements for biologics development and manufacturing, including drafting, interpreting, and implementing quality assurance policies and procedures as well as establishing document management activities.
- Significant experience with establishing QMS solutions (especially for a multi-client environment), supporting on-site audits, and ensuring finished product quality.
- Ability to independently assess R&D and manufacturing activities for compliance to regulatory standards for cGMPs, identify areas of non-compliance, recommend corrective action, as well as participate or lead team-based solutions.
- Demonstrated management/supervisory experience, with a history of developing a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives.
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or