SR. Mgr./AD Quality Control

Hands-on QC leader responsible for overseeing daily QC analytical operations while strengthening quality systems, laboratory execution discipline, and cross-functional partnerships to support growth as a contract manufacturing organization. This role operates above pure management, owning IND support studies, validations, QC release and stability programs, leading OOS/OOT investigations, authoring and defending CAPAs, and partnering closely with QA and Manufacturing for timely, compliant batch disposition across clinical and commercial peptide programs. Remains close to laboratory work to understand method performance, execution gaps, and build a team capable of holding both phase-appropriate clinical standards and rigorous commercial GMP standards in a fast-moving, dynamic environment.

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.
• 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, establish corrective and preventive actions, 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.

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.

Pay

The anticipated base salary range for this position is $150,000 – $210,000 annually. Actual compensation will be determined based on factors including relevant experience, skills, qualifications, and internal equity.