Join PolyPeptide as our QA Manager of Quality Systems & Compliance, where you’ll lead the programs that safeguard our site’s quality, regulatory integrity, and inspection readiness. In this pivotal role, you will oversee our Quality Management System (QMS), guide the team responsible for deviations, CAPAs, and investigations, and serve as a key leader during regulatory inspections and customer audits. If you're passionate about driving excellence and elevating quality culture, this is a high-impact opportunity to make your mark.

What You’ll Do

• Lead, coach, and develop a team of quality specialists; support training, performance goals, and succession planning.

• Oversee timely and compliant management of deviations, CAPAs, complaints, and investigations.

• Drive continuous improvement of quality systems, procedures, and risk mitigation strategies.

• Review and evaluate change controls to ensure complete and compliant documentation.

• Prepare for, host, and support regulatory, customer, and internal audits.

• Maintain site compliance with cGMP, ICH guidelines, and global regulatory expectations.

• Support site training programs and ensure strong documentation, data integrity, and quality metrics performance.

• Prepare quality reports and analyses to support operational decision-making and audit readiness.

What You Bring

• Bachelor’s degree in Life Sciences, Chemistry, Pharmaceutical Sciences, or related field (advanced degree preferred).

• 5–7 years of pharmaceutical QA experience, with 3+ years in a leadership role.

• Strong understanding of cGMP, ICH Q7, 21 CFR Part 11, EU GMP Annex 11, and quality system requirements.

• Experience managing QMS platforms (AX Dynamics, eQMS, etc.).

• Exceptional communication, leadership, problem-solving, and organization skills.

• Ability to influence cross-functional teams and manage multiple priorities in a fast-paced environment.

Why PolyPeptide?

At PolyPeptide, you’ll be part of a global CDMO where quality isn’t just a department—it’s our identity. You’ll drive initiatives that strengthen our manufacturing excellence, audit readiness, and customer trust, all while building and developing a team that shares your commitment to world-class compliance.

Lead with purpose. Shape the quality foundation behind life-changing therapeutics, apply today and help drive excellence at PolyPeptide.

 Salary: $105k-$115k

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.