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Senior Supplier Quality Assurance Manager

2 months ago

Boston, United States Talnt LLC Full time

About the job Senior Supplier Quality Assurance Manager

Responsibilities: Manage systems and processes to oversee supplier quality, including handling the supplier change control system, supplier investigations, and supplier validation activities. Oversee combination product development projects, ensuring compliance with quality standards and regulations. Manage and oversee the change control system, including initiating and processing change controls for both internal and external modifications affecting materials, systems, and documentation. Facilitate reviews and meetings for change control, tracking the implementation and closure of action items. Support quality assurance operations by reviewing production records, testing documentation, and overseeing lot disposition activities to ensure compliance with quality agreements and GMP standards. Conduct investigations into supplier and internal deviations, performing root cause analyses and developing corrective and preventive actions (CAPAs). Serve as a lead on quality assurance for combination product projects, including managing risk assessments and maintaining design history files. Author, review, and revise standard operating procedures (SOPs) and ensure all quality documentation complies with GMP, regulatory requirements, and corporate standards. Assist in audit preparations and follow-ups, both internal and external, to maintain compliance standards. Participate in and drive quality system improvements.

Qualifications: Bachelors degree or higher in a technical or scientific discipline. Minimum of 10 years' experience in a GMP-related field, with at least 7 years in quality assurance within the pharmaceutical or medical device industry. Comprehensive knowledge of GMP requirements and regulatory standards including 21 CFR Parts 4, 210, 211, and 820. Demonstrated understanding of manufacturing processes, technological transfers, and analytical testing in pharmaceutical and medical device contexts. Strong capabilities in conducting detailed investigations, including root cause analysis and CAPA management.

Preferred Qualifications: Experience with pharmaceuticals and medical devices strongly preferred. Proficient in quality system regulations across multiple standards and guidances, such as ICH guidelines. Exceptional communication and interpersonal skills to effectively interact at all organizational levels. Proven ability to manage multiple priorities and timelines in a dynamic, fast-paced environment. Strong organizational skills with an emphasis on detail and a commitment to high-quality work.

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