Associate Director/Director Quality Control

Key Responsibilities

• 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.
• 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.
• Cover 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.

Qualifications

• 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 analytical methods relevant to peptide API characterization, including purity, identity, impurity profiling, and stability testing.
• Demonstrated ownership of OOS/OOT investigations — including Phase I laboratory investigation execution and Phase II root cause analysis — under 21 CFR 211.192 and FDA OOS guidance expectations.
• Working knowledge of analytical method validation and transfer per ICH Q2(R1) and USP requirements in a GMP QC context.
• Familiarity with phase-appropriate GMP requirements for clinical trial API material under 21 CFR Part 211 and ICH Q7; ability to calibrate QC standards appropriately across early-phase and commercial programs.
• Demonstrated ability to work effectively in a fast-moving, deadline-driven, CDMO or similarly dynamic organization where priorities shift and QC decisions must be made with urgency and sound risk judgment.
• Strong communication and collaboration skills across QA, Manufacturing, Regulatory, and client-facing functions.
• Familiarity with Empower, or equivalent data systems expected given the analytical scope of the role.

Compensation

This role offers a competitive base salary in the range of $165 – $225k, plus performance-based bonus. Final compensation will be determined based on experience, qualifications, and overall fit.

About Mix Talent

Mix Talent is a specialized recruiting partner focused on building high-performing teams across the life sciences industry. We partner closely with innovative companies to identify talent that drives meaningful impact.