Summary:

The Manager, Quality Assurance, External Manufacturing is responsible for overseeing quality activities at contract manufacturing organizations (CMOs), ensuring compliance with cGMP standards, and driving performance through KPIs and continuous improvement initiatives. This role leads batch disposition, reviews critical GMP documentation, supports PPQ activities, and collaborates cross-functionally to resolve complex manufacturing and quality issues. The position requires strong expertise in pharmaceutical quality systems, regulatory requirements, and risk management, along with leadership, problem-solving, and communication skills to support both clinical and commercial operations.

Essential Functions:

• Provide Quality Assurance oversight of Contract Manufacturing Organizations (CMOs).
• Develop and report metrics and key performance indicators (KPIs) to evaluate CMO performance.
• Represent Quality Assurance at internal cross-functional meetings and Joint Project Team meetings.
• Lead polysaccharide batch disposition activities, including review of executed batch records, environmental monitoring data, and quality control results.
• Review and approve GMP documentation, including master batch records, deviations, risk assessments, change controls, and CAPAs.
• Drive resolution of quality performance issues in collaboration with contract manufacturers.
• Support Process Performance Qualification (PPQ) activities.
• Develop, implement, and maintain quality procedures, policies, and standards.
• Collaborate with key stakeholders to develop solutions to complex manufacturing and quality issues.
• Participate in compliance audits and regulatory inspections, as required.
• Promote a strong quality mindset and a culture of quality excellence across all activities.

Requirements: 

• Bachelor’s degree in chemistry, Biology, Pharmacy, Engineering, or a related scientific discipline.
• Minimum 5 years of experience in managing CMO quality, and quality systems management within the pharmaceutical, biotechnology, or life sciences industry. Other combinations of education and experience may be considered.
• Experience in batch record review, deviations and Out of Specification (OOS) investigations.
• Thorough knowledge of cGMP, ICH guidelines, FDA/EMA, Swiss medic regulations, and international pharmaceutical quality standards.
• Experience applying Quality Risk Management principles.
• Experience supporting both clinical and commercial products preferred.
• Strong leadership, management, and process improvement skills.
• Excellent organizational skills with strong attention to detail.
• In-depth understanding of biologics manufacturing operations.
• Proven ability to prioritize multiple assignments in a fast-paced, changing environment.
• Strong problem-solving abilities, including managing complex investigations and root cause analyses.
• Excellent written and verbal communication skills, with the ability to clearly present quality topics and risk-based decisions to cross-functional teams.