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 followups 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 GMPrelated 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 Partsand 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 fastpaced environment.
• Strong organizational skills with an emphasis on detail and a commitment to highquality work.

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Remote Work :

No