Head of Quality Assurance

About the Role

The Head of Quality Assurance is responsible for leading site Quality Assurance activities and ensuring compliance with applicable FDA, EMA, ICH, cGMP, corporate, and customer requirements. You will oversee key QA functions including deviations, batch record review, product release, CAPA, change control, supplier quality, complaints, document control, annual product reviews, and GMP training. In addition to overseeing day-to-day Quality operations, you will help shape the site's long-term Quality strategy.

What You Will Do

• Provide strategic and operational leadership for the site Quality Assurance organization.
• Lead and oversee QA activities including deviations, batch record review, annual product review, clinical and commercial product release, CAPA, change control, complaints, supplier quality, document control, and GMP training.
• Ensure site Quality Systems remain compliant with cGMP, FDA, EMA, ICH, corporate standards, and customer requirements.
• Evaluate the effectiveness of the Quality System and identify opportunities to improve compliance, efficiency, and operational performance.
• Monitor regulatory developments and incorporate applicable FDA, EMA, ICH, and industry expectations into site Quality practices.
• Maintain a strong state of regulatory inspection and customer audit readiness.
• Lead and support regulatory inspections, customer audits, and associated responses and commitments.
• Partner with Regulatory Affairs, Manufacturing, Development, Commercial teams, and Corporate Quality to support customer projects, regulatory submissions, and business priorities.
• Support the harmonization of global Quality standards and practices across PolyPeptide Group sites.
• Provide Quality leadership for the manufacture and release of clinical and commercial APIs and raw materials.
• Build strong relationships with pharmaceutical and biotechnology customers and provide Quality leadership during customer interactions.
• Establish goals, development plans, and training opportunities for direct reports.
• Coach and develop Quality leaders and team members with a focus on succession planning and long-term organizational capability.
• Monitor Quality KPIs and drive accountability for deviations, CAPAs, audits, training, product release, and other key Quality metrics.
• Identify and lead continuous improvement initiatives that strengthen both Quality compliance and operational efficiency.

What We Are Looking For

Education and Experience: Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or a related discipline. 10+ years of progressive Quality Assurance experience within a pharmaceutical, biotechnology, CDMO, or similarly regulated environment. Minimum of 5 years of experience in a senior Quality Assurance leadership role. Demonstrated experience leading teams and managing complex Quality operations. Experience with peptide or oligonucleotide manufacturing is highly desirable. Advanced education or certifications in GMP compliance, Quality Systems, or project management are a plus.

Quality and Regulatory Expertise: Deep knowledge of cGMP requirements, FDA and EMA regulations, and ICH guidelines. Strong understanding of pharmaceutical Quality Systems and Quality risk management. Demonstrated experience supporting or leading FDA, EMA, or other regulatory inspections. Experience managing customer and client audits in a pharmaceutical or CDMO environment. Strong knowledge of deviations, CAPA, change control, complaints, supplier quality, document control, batch record review, product release, and training systems. Experience supporting clinical and commercial product release. Ability to evaluate Quality trends, metrics, and emerging regulatory expectations and translate them into practical improvements.

Leadership and Business Skills: Proven ability to lead, develop, and motivate high-performing Quality teams. Strong judgment and confidence making Quality and compliance decisions in a fast-paced environment. Ability to balance regulatory compliance, customer commitments, operational priorities, and business needs. Strong communication and executive-level presentation skills. Demonstrated ability to build productive relationships with pharmaceutical and biotechnology customers. Strong cross-functional collaboration skills and the ability to influence across organizational boundaries. Ability to manage multiple priorities, deadlines, and complex initiatives simultaneously. Strong problem-solving, decision-making, and continuous improvement mindset.