Head of Quality Assurance - Torrance

About the role

As Head of Quality Assurance, you will play a critical role in ensuring the successful development, manufacture, and release of high-quality APIs while helping strengthen quality systems, develop future leaders, and support PolyPeptide’s commitment to exceptional quality and on-time delivery.

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. You will assess opportunities to strengthen and modernize the Quality System, support regulatory inspections and customer audits, partner with Corporate Quality on global initiatives, and develop the next generation of Quality leaders. This role is ideal for someone who can move confidently between strategic leadership, technical Quality decisions, team development, customer interaction, and operational execution.

Responsibilities

• 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