Head of Quality Assurance

About the role

PolyPeptide supports pharmaceutical and biotech companies in developing and manufacturing peptide-based therapies. It is looking for a Head of Quality Assurance in Torrance, CA, to lead the site's Quality Assurance organization. This is a full-time, highly visible leadership role combining deep technical knowledge of GMP quality systems with the ability to lead teams, influence cross-functional partners and keep the site ready for regulatory inspections.

Key responsibilities

• Lead site Quality Assurance activities and ensure compliance with FDA, EMA, ICH, cGMP, corporate and customer requirements.
• Oversee QA functions such as deviations, batch record review, product release, CAPA, change control, supplier quality, complaints, document control, annual product reviews and GMP training.
• Shape the site's long-term Quality strategy, modernize the Quality System and support regulatory inspections and customer audits.
• Partner with Regulatory Affairs, Manufacturing, Development, Commercial teams and Corporate Quality on global initiatives.
• Provide Quality leadership for the manufacture and release of clinical and commercial APIs and raw materials, and lead customer interactions.
• Develop direct reports, coach Quality leaders and build succession planning.
• Monitor Quality KPIs and drive continuous improvement.

Required profile

• Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Life Sciences or a related discipline.
• 10+ years of progressive Quality Assurance experience in a pharmaceutical, biotechnology, CDMO or similar regulated environment.
• At least 5 years in a senior Quality Assurance leadership role.
• Demonstrated experience leading teams and managing complex Quality operations; peptide or oligonucleotide manufacturing experience highly desirable.

Required skills

• Deep knowledge of cGMP, FDA and EMA regulations and ICH guidelines.
• Experience supporting or leading FDA, EMA or other regulatory inspections and managing customer audits.
• Strong knowledge of deviations, CAPA, change control, complaints, supplier quality, document control, batch record review and product release.
• Leadership, communication and cross-functional collaboration skills.

What we offer

• Salary of $160k - $210k.
• The chance to shape Quality strategy, strengthen global Quality Systems and develop a team of Quality professionals.