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.