Kelly Science, Engineering, Technology & Telecom

Compensation

Full Description

Lead Auditor / Assistant Director, GMP Quality Systems Workplace: Carlsbad, CA (on-site preferred) or remote (quarterly travel required, expenses covered) Salary range: $100,000–$140,000 + 15% performance bonus + equity (RSUs & stock options) About the Company Our client is a commercial-stage biotechnology company recognized for pioneering RNA-targeted medicines and advanced gene technologies. With multiple approved therapies, a robust pipeline, and a shift toward commercial GMP operations, the company is expanding its Quality Systems team to ensure global inspection readiness and regulatory excellence. Position Overview We’re seeking an experienced GMP Auditor to step into a strategic Assistant Director-level role within our Quality Systems and Vendor Management team. Reporting to the Director of GxP Quality Systems, you will own and elevate the Internal Audit Program while supporting GMP vendor management. This is a high-impact, individual contributor role—ideal for someone who thrives on leadership through influence, program ownership, and cross-functional collaboration. Key Responsibilities • Lead and modernize the Internal Audit Program: • Conduct risk-based audits of internal GMP functional areas. • Transition the program beyond compliance checks to a holistic, risk-driven model. • Ensure inspection readiness for commercial operations. • Conduct hands-on audits with emphasis on: • Computer System Validation (CSV) & Data Integrity • Drug product fill/finish processes • Combination products (e.g., auto-injector assembly) • Vendor Management: • Perform GMP vendor qualification, ongoing audits, and performance monitoring. • Oversee Quality Agreements, Change Notifications, and vendor-related CAPAs. • Partner with stakeholders to drive vendor compliance and continuous improvement. • Stakeholder Collaboration: • Work cross-functionally with QA, manufacturing, and global quality partners. • Influence teams to recognize risks, strengthen systems, and drive enhancements. • Quality Leadership: • Demonstrate ownership, initiative, and strong communication skills. • Serve as a quality culture ambassador—driving agility, compliance, and continuous improvement. Qualifications Required: • Bachelor’s degree in a Life Sciences field (Chemistry, Biology, Biotech, Engineering, etc.). • 8+ years’ experience in life sciences or pharma, with at least 5 years focused on GMP auditing/vendor management. • Strong knowledge of global GMP regulations (FDA, EMA/Eudralex, ICH, MHRA, Health Canada, etc.). • Proven experience with CSV audits, data integrity, and drug product fill/finish. • Ability to lead programs independently, influence stakeholders, and communicate effectively at all levels. • Track record of working in mid-to-large pharma/biopharma environments (preferred over small biotech only). Preferred: • Experience with antisense oligonucleotide manufacturing. • Exposure to combination product/device assembly. • Familiarity with electronic audit systems (e.g., TrackWise, Veeva). • Continuous improvement mindset with demonstrated program-building skills. • Why Join Us • Be part of a growing Quality Systems team shaping the company’s commercial readiness. • Work in a collaborative, global, and innovative environment with colleagues across the U.S. and Europe. • Competitive compensation package: base + annual bonus + equity. • Flexibility: onsite in Carlsbad preferred, but remote considered for strong candidates (quarterly travel required, fully covered).