Head of Quality AssuranceLocation: Torrance, CA
| Employment Type: Full-Time
Lead Quality Strategy, Regulatory Excellence, and High-Performing TeamsThis is a highly visible leadership role for an experienced QA professional who combines deep technical knowledge of GMP quality systems with the ability to lead teams, influence cross-functional partners, and maintain a strong state of regulatory inspection readiness.
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.
About the RoleThe 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.
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.
- Perform additional responsibilities as needed to support the Quality organization and site operations.
What We Are Looking ForEducation 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.
Key Areas of Leadership- Quality Systems & Regulatory Compliance - Maintain effective, compliant, and inspection-ready Quality Systems.
- Leadership & Team Development - Build capability, develop future leaders, and strengthen succession planning.
- Operational QA Management - Ensure efficient Quality support for manufacturing, testing, and product release.
- Cross-Functional Collaboration - Partner effectively across Manufacturing, Development, Regulatory Affairs, Commercial teams, and Corporate Quality.
- Regulatory Inspection Readiness - Maintain a strong state of preparedness for regulatory inspections and customer audits.
- Continuous Improvement - Identify opportunities to improve Quality processes while maintaining the highest compliance standards.
Salary: $160k - $210k
