Senior Supplier Quality Assurance

Location:

Contract:

Are you looking for a unique opportunity to drive quality excellence in pharmaceutical manufacturing Kelly FSP is seeking an experienced Senior Supplier Quality Assurance professional to actively support supplier selection, qualification, product transfers, process validations, and provide comprehensive quality oversight for API manufacturers. This position is part of an important API Restructuring Project.

Key Responsibilities:

• Support the selection and qualification of suppliers through due diligence and audits.
• Provide quality oversight for product transfers and process validations, including equipment qualification.
• Ensure all products and materials supplied are manufactured, packaged, analyzed, and distributed in compliance with company and regulatory standards.
• Offer technical advice, guidance, and coaching to external party quality representatives to ensure adherence to Current Good Manufacturing Practices (cGMP) and legal regulations.
• Review and update Quality Agreements and Commercial Agreements.
• Serve as point of contact for key suppliers and liaise between external partners and internal teams.
• Support audit planning and remediation, regular site visits, training, and coaching.
• Review deviation investigations, support Product Quality Complaint (PQC) investigations, and manage technology transfer projects.
• Assist partners in preparing for regulatory inspections.
• Participate in cross-functional investigations and project teams.
• Perform additional quality-related activities as required.

Qualifications & Experience:

Required:

• Bachelor's degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering, or related field.
• 8+ years of experience in manufacturing, technology, and/or quality operations in a regulated (EU/FDA) pharmaceutical or medical device environment.
• Expertise in Quality Systems, Quality Assurance, Quality Control, and regulatory requirements.
• Strong knowledge of cGMP, compliance, risk management, and regulatory interpretation.
• Experience auditing external/internal manufacturers and testing laboratories.
• Ability to work independently in a virtual-management environment.
• Exceptional problem-solving, communication, negotiation, and leadership skills.
• Proficiency in English; a second language is preferred.
• Willingness and ability to travel globally (50%).

Preferred:

• Auditor training (e.g., ISO 9001), experience in regulatory or industry forums.
• Proven experience leading cross-functional teams and process improvement initiatives.
• Experience with Due Diligence teams at senior management level.