Member of the Quality Assurance group providing quality and compliance support for all aspects of process development, commercial manufacturing, testing and release of drug substance/drug product.
Support internal and external Quality Systems and Operations, such as facility/equipment, materials, production, laboratory, packaging/labeling and quality. Assure compliance with current GMPs.
- Manage and coordinate QA staff and/or consultants towards the timely completion of assigned duties and responsibilities.
- Manage Deviation, CAPA, Change Control. Supplier corrective actions, BPDR and Recall Quality System Elements (QSE)
- Lead Change Control Board
- Manage Supplier Quality
- Lead/conduct/support Audits (internal and external). Travel for vendor/supplier audits, as needed
- Responsible for Specification Management
- Responsible for other cross functional activities, as needed
"We are an equal opportunity employer M/F/D/V"
Minimum of a BS in Biology, Chemistry, Microbiology or related field.
Must have a minimum of 7-10 years of relevant experience within Quality or Compliance
Must have previous pharmaceutical or biopharmaceutical/vaccine experience
Industry experience with aseptic operations preferred
Experience in maintaining CGMP compliance a must; implementing a plus
The ability to coordinate multiple priorities in a fast paced environment
Solid organization, analytical and problem solving skills
Strong communication skills with the ability to interact with all levels throughout the organization
In addition, demonstrated excellent interpersonal skills and flexibility; demonstrated ability for successful leadership, influence and negotiation a plus
Must have a demonstrated understanding and/or working knowledge of CGMP regulations
Experience managing subordinates and/or projects preferred M*
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