QA DIRECTOR

CPC Scientific is a globally recognized and leading CDMO specializing in synthetic peptide and oligonucleotide production, with one of the largest research peptide facilities in the world. CPC Scientific works directly with leaders in the biotechnology and pharmaceutical industries to bring life‑changing therapeutics and diagnostics to market ranging from early drug discovery stages through clinical trials to commercial manufacturing.

CPC Scientific is seeking a QA Director, to fill a full‑time, on‑site role in our Rocklin, CA facility. This position will report directly to the CEO and is responsible for overseeing the strategic planning and operational delivery of all QA functions at the new greenfield peptide CDMO manufacturing site.

Will lead the full‑lifecycle quality governance throughout site construction, facility validation, trial production and commercial launch. Will establish comprehensive QMS and document control framework fully compliant with FDA 21 CFR Part 210/211, EU GMP, ICH Q Guidelines, USP & EP. Will be responsible for the end‑to‑end ownership of batch release, deviation/change control/CAPA, validation, data integrity, audit readiness and client quality liaison.

This position will build the QA team, manage annual department budget, embed risk‑based quality culture, enable smooth commercial commissioning in Q4 2026, sustain permanent regulatory inspection readiness, and ensure consistent compliant & efficient operation of the site quality management system.

This position will interact with all levels within the organization. Professionalism and maintaining confidentiality are an integral part of the job.

• Develop medium & long‑term site quality strategy aligned with multi‑client, multi‑product commercial peptide CDMO business objectives, deliver annual quality roadmap, department KPIs and yearly budget plan;
• Act as the quality representative in leadership meetings, report quality trends, compliance risks and critical quality incidents to Site Quality Head and China HQ;
• Establish unified site‑wide quality culture, cascade compliance‑first, proactive risk and data integrity mindset across all departments;
• Benchmark against global top‑tier peptide CDMO quality standards, continuously optimize site quality governance model and formulate long‑term quality improvement roadmap.

• Take full ownership of site‑wide compliance with FDA 21 CFR Part 210/211, ICH Q7/Q9/Q10, EU GMP, USP/EP and all applicable global regulatory standards;
• Sustain permanent site inspection readiness, fully lead FDA, EMA and other global regulatory on‑site inspections, serve as primary site QA contact during all regulatory visits;
• Review regulatory submissions, quality agreements, inspection observation responses and remediation CAPA reports, ensure full compliance with all regulatory documentation;
• Monitor ongoing regulatory and pharmacopoeia updates globally, timely revise internal QMS documents and deliver site‑wide regulatory training sessions;
• Govern end‑to‑end third‑party GMP audits and client quality audits, coordinate document preparation, on‑site walkthrough, observation classification, corrective action planning and full closure.

• Deliver full QA oversight over commercial peptide synthesis, purification, fill‑finish and packaging operations, covering pilot, scale‑up and full commercial production batches;
• Lead full QA governance for technology transfer, manufacturing process changes and process validation, assess quality risks associated with peptide manufacturing workflows;
• Hold full authority for batch release of peptide drug substances, intermediates and drug products, conduct comprehensive evaluation of batch records, test results, deviations and validation status to issue release decisions;
• Act as dedicated QA liaison for global CDMO clients, align with contractual quality requirements, respond to client quality inquiries, coordinate audit, sample and regulatory filing related quality matters;
• Lead cross‑functional investigations for client complaints and product quality deviations, design long‑term…