Quality Assurance Leader — GMP Strategy & Compliance

PolyPeptide US; Torrance (CA); On-site; USD 160,000 - 210,000; Full time

Job summary

PolyPeptide US in Torrance, CA, is seeking a Head of Quality Assurance to provide strategic leadership and operational oversight across the QA organization, ensuring compliance with FDA, EMA, ICH, and cGMP requirements.

This senior role leads deviations, batch record review, product release, CAPA, change control, supplier quality, audits, document control, annual product reviews, and GMP training while shaping the site’s long-term Quality strategy and developing future leaders for sustained

Qualifications

• Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or a related discipline.
• 10+ years of progressive QA 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.

Responsibilities

• Provide strategic and operational leadership for the site Quality Assurance organization.
• 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.
• Perform additional responsibilities as needed to support the Quality organization and site operations.

Skills

Leadership

GMP knowledge

Quality Assurance

Cross-functional collaboration

Regulatory readiness

Education

Bachelor’s or Master’s in Chemistry, Pharmaceutical Sciences, Life Sciences, or related discipline

Job description

PolyPeptide US in Torrance, CA, is seeking a Head of Quality Assurance to provide strategic leadership and operational oversight across the QA organization, ensuring compliance with FDA, EMA, ICH, and cGMP requirements.

This senior role leads deviations, batch record review, product release, CAPA, change control, supplier quality, audits, document control, annual product reviews, and GMP training while shaping the site’s long-term Quality strategy and developing future leaders for sustained