Associate Director​/Director Quality Control

Associate Director, Quality Control

Position Summary:

The Associate Director, Quality Control is a hands‑on QC leader responsible for overseeing daily QC analytical operations while strengthening the quality systems, laboratory execution discipline, and cross‑functional partnerships needed to support our growth as a contract manufacturing organization. This role operates above a pure management level: the individual must own IND support studies and validations, QC release and stability programs, lead OOS/OOT investigations, author and defend CAPAs, and partner closely with QA and Manufacturing to enable timely, compliant batch disposition across both clinical and commercial peptide programs.

At the same time, this person must remain close to the work — spending meaningful time in the laboratory to understand how analytical methods perform in practice, where execution gaps exist, and how to build a team capable of holding both phase‑appropriate clinical standards and rigorous commercial GMP standards simultaneously. This environment moves fast, changes direction, and expects QC leadership to make risk‑based decisions with urgency and confidence.

• Provide direct oversight of daily QC operations, including IND support studies and validations, release testing, stability programs, and reference standard programs.
• Ensure testing is executed accurately, documented completely, and completed on time to support batch release commitments across clinical and commercial programs.
• Monitor laboratory execution, identify operational gaps, and prioritize QC workload based on compliance risk, client deadlines, and business needs.
• Maintain instrument qualification, method lifecycle management, and laboratory readiness at a standard that supports both FDA and client audit expectations.
• Own OOS/OOT investigations from initiation through closure — lead Phase I laboratory investigations, determine adequacy of laboratory error assignable cause, and drive Phase II investigations in collaboration with QA and Manufacturing when required.
• Author technically sound investigation reports that clearly document hypotheses tested, evidence evaluated, root‑cause conclusions, and disposition rationale; defend these conclusions to QA, clients, and regulatory agencies.
• Own CAPA authorship for QC‑initiated quality events: define problem statements, execute root‑cause analysis using appropriate methodology, establish corrective and preventive actions that address systemic causes, and define measurable effectiveness checks.
• Oversee QC method transfers, validations, and verifications in coordination with analytical development; ensure methods are fit‑for‑purpose for GMP release and stability testing prior to implementation.
• Serve as a QC subject‑matter expert during method troubleshooting, providing technical guidance to analysts and driving resolution of recurring method performance issues.
• Review and approve analytical methods, specifications, validation protocols and reports, and associated QC documentation.
• Support specification‑setting and release criteria development for new peptide API programs, collaborating with QA, Regulatory, and client CMC teams as needed.
• Serve as the primary QC subject‑matter expert and front‑room representative for regulatory inspections and client audits.
• Lead audit and inspection readiness for the QC function on an ongoing basis; author or review responses to findings, drive corrective actions to closure, and ensure remediation is operationally practical, sustainable, and completed within committed timelines.
• Conduct and participate in internal QC laboratory audits to proactively identify gaps in execution, documentation, or compliance posture.

• B.S., M.S., or Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or a closely related scientific discipline.
• Typically 8–12+ years of progressive analytical and QC experience in GMP pharma, biotech, or CDMO environments, with at least 3 years in a leadership or senior individual‑contributor role overseeing QC operations or analytical quality functions.
• Hands‑on proficiency with HPLC, LC‑MS, and UV‑based…