QC DIRECTOR

CPC Scientific (CPC) 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 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 is seeking a Director of Quality Control (QC) to fill a full‑time, on‑site role in our Rocklin, California facility. This position will report directly to either the CEO or QA Director and is responsible for overseeing full lifecycle planning, greenfield construction and daily operation of the QC laboratory in the new peptide CDMO facility while delivering lab compliance and technical excellence.

The person in this role will establish a comprehensive laboratory QC framework fully aligned with FDA 21 CFR Part 210/211, ICH Guidelines, EU GMP, USP & EP. Manage full testing workflow for raw materials, intermediates, finished goods, cleaning validation and stability samples, the full lifecycle of analytical methods, instrument asset management, and closed‑loop handling of lab OOS/OOT/deviations/CAPAs. Lead all QC‑related activities during FDA, client and third‑party audits.

Build and manage the QC team, department budget and lab EHS governance. In addition, provide end‑to‑end QC support for commercial peptide synthesis, purification, fill‑finish, technology transfer and process validation. Will also strictly enforce ALCOA+ data integrity, enable smooth site commissioning in Q4 2026, sustain permanent inspection readiness, and deliver compliant testing and Certificates of Analysis consistently.

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

• Develop medium to long term lab strategy, annual department objectives and operational plans tailored to peptide CDMO business, aligning with site commercial schedules and global client delivery commitments.
• Act as senior QC representative in site leadership meetings and executive client communications, submit lab KPI and critical technical risk reports.
• Foster lab culture centered on scientific rigor, compliance accountability and continuous improvement, embed data integrity mindset among all lab staff.
• Oversee pre‑construction lab layout design, resource allocation, staffing plan, annual budget formulation and cost optimization.

• Ensure 100% compliance of all lab activities with FDA 21 CFR, ICH, EU GMP, USP/EP, cGMP, GDP and ALCOA+ data integrity principles.
• Maintain permanent FDA inspection readiness, coordinate all QC audit documentation, on‑site walkthrough and observation remediation tracking.
• Establish and continuously update full suite of lab SOPs, specifications, sampling protocols, instrument SOPs and record templates.
• Monitor global pharmacopoeia and regulatory updates, deliver site‑wide lab regulatory training and align internal systems timely.
• Implement full lab EHS control covering reagents, reference standards, hazardous waste, gas cylinders and cleanroom PPE requirements.

• Oversee sampling and full testing for raw materials, packaging, intermediates, peptide DS/DP, cleaning validation, environmental, purified water and stability samples.
• Control testing turnaround time to deliver accurate, efficient analytical data and timely release with official CoA issuance.
• Own full lifecycle management of analytical methods including development, transfer, qualification, validation and annual review.
• Govern IQ/OQ/PQ, periodic calibration and preventive maintenance for HPLC, MS, microbial and all lab instrumentation.
• Review and approve all raw analytical data, lab reports, validation protocols/reports, specifications and batch test records.

• Lead all OOS, OOT, atypical result and lab deviation investigations, conduct scientific root cause analysis, develop CAPAs and track…