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We're looking for a Quality Manager V
, working in Pharmaceuticals and Medical Products
industry in 1 Discovery Drive, Swiftwater, Pennsylvania, 18370, United States
- Represent the site quality organization with expertise in Data Integrity.
- Maintain currency with U.S. and European regulations related to Data Integrity.
- Perform Data Integrity risk assessment of manufacturing and laboratory systems.
- Evaluate proposed and existing manufacturing equipment, instrument systems and laboratory applications for Data Integrity gaps.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- Bachelors degree (or equivalent) required in a relevant scientific discipline
- Relevant quality assurance experience (comparable to 10+ years) including expertise in GMP regulations gained from time served in a pharmaceutical, biotechnology and/or medical device industry
- 5+ years working in a GMP regulated environment
- 3+ years of experience quality role
- 3+ years of experience in a computer systems validation or equivalent combination of education, training and experience that provides the knowledge, skills and abilities to perform the duties of the job
- Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA guidance on Data Integrity
- Expertise in all aspects of pharmaceutical GMP regulations (e.g. quality systems, root cause analysis and Total Quality Management)
- Proficiency in Microsoft Office (Word, Excel, PowerPoint)
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?