Senior Supplier Quality Assurance Manager

2 weeks ago


Boston, United States Talnt Full time
Job DescriptionJob DescriptionResponsibilities:
  • 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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