Senior Manager, Global Supplier Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee quality assurance activities for strategic and high-risk external suppliers that support both commercial and development operations.

• Collaborate with Procurement, Supply Chain, Manufacturing, Technical Operations, Regulatory Affairs, and Quality teams on supplier lifecycle initiatives.

• Perform supplier performance evaluations, risk assessments, and governance activities.

• Assist in domestic and international GMP audits involving contract manufacturers, laboratories, API manufacturers, packaging suppliers, distributors, and outsourced GxP providers.

• Implement the global, risk-based supplier audit program and ensure the accuracy and compliance of audit reports.

• Analyze supplier feedback and CAPA plans, while assessing supplier quality concerns.

• Aid in regulatory inspections and maintain inspection readiness related to supplier quality.

• Track supplier quality performance, metrics, KPIs, trends, and emerging risks.

• Suggest risk mitigation strategies and improvements for supplier performance, escalating significant issues as necessary.

• Propose continuous enhancements to supplier quality processes, audit efficiency, and operational effectiveness.

• Assist in optimizing electronic Quality Management Systems, such as TrackWise Digital.

• Create and update supplier quality procedures, work instructions, templates, and training resources.

• Mentor colleagues and auditors, engage in cross-functional projects, and contribute to knowledge sharing and ongoing improvement.

⛳️ Requirements

• A Bachelor's degree in Biology, Chemistry, Engineering, Pharmacy, or another relevant scientific field.

• At least 6 years of progressive experience in Quality Assurance, Supplier Quality, External Manufacturing Quality, Manufacturing Quality, or Quality Systems.

• Experience must be within the pharmaceutical, biotechnology, or medical device sectors.

• A minimum of 3 years of experience in independently planning, executing, and leading GMP audits of external suppliers.

• Strong understanding of FDA, EMA, ICH, and other relevant global GMP regulations.

• Experience in supplier qualification, oversight, audit findings, CAPA management, risk assessments, and performance monitoring.

• Capacity to support supplier initiatives and collaborate effectively with cross-functional stakeholders.

• Excellent communication, analytical, organizational, and problem-solving abilities.

• Proficiency in influencing cross-functional stakeholders.

• Willingness to travel domestically and internationally, up to 50% of the time.

• ASQ Certified Quality Auditor (CQA), Lead Auditor certification, or an equivalent qualification is preferred.

• Experience assisting with commercial and development-stage pharmaceutical products is preferred.

• Familiarity with TrackWise Digital is preferred.

• Experience in supporting regulatory inspections and supplier remediation efforts is preferred.

• Experience in developing or enhancing supplier quality processes, audit programs, or governance activities is preferred.

🏝️ Benefits

• Incentive opportunity.

• Comprehensive medical coverage.

• Dental coverage.

• Vision coverage.

• Prescription drug coverage.

• Company-provided basic life insurance.

• Accidental death and dismemberment insurance.

• Short-term disability insurance.

• Long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) match.

• Flexible time off.

• Paid holidays.

• Paid leave programs.

• Additional company-provided benefits.