Sr. Manager/AD Quality Control

Mix Talent; Milpitas (CA); On-site; USD 165,000 - 225,000; Full time

Job summary

Mix Talent in Milpitas, CA, seeks an Associate Director, Quality Control who will lead daily QC operations, own IND support studies, and drive CAPA and investigations to ensure compliant batch disposition across clinical and commercial peptide programs.

This hands‑on leader will stay close to analytical work, oversee method transfers, validations, and audits, and partner with QA, Manufacturing, and Regulatory to sustain GMP standards.

Qualifications

• B.S., M.S., or Ph.D. in Analytical Chemistry or closely related scientific discipline.
• 8–12+ years in GMP pharma/biotech/CDMO with at least 3 years in leadership or senior individual‑contributor role.
• Hands‑on proficiency with HPLC, LC‑MS, UV methods for peptide API characterization (purity, identity, impurity profiling, stability).
• Experience leading OOS/OOT investigations under 21 CFR 211.192 and FDA guidance.
• Knowledge of analytical method validation and transfer per ICH Q2(R1) and USP in GMP QC.
• Familiarity with GMP requirements for clinical trial API under 21 CFR Part 211 and ICH Q7; calibrate QC standards.
• Ability to work in fast‑moving environments with risk‑based decisions.
• Strong cross‑functional collaboration with QA, Manufacturing, Regulatory, and clients.
• Familiarity with Empower or equivalent data systems.

Responsibilities

• Provide direct oversight of daily QC operations including IND support studies, release testing, stability programs, and reference standard programs.
• Ensure testing is accurate, well‑documented, and timely for batch release across clinical and commercial programs.
• Monitor laboratory execution, identify gaps, and prioritize QC workload based on compliance risk and deadlines.
• Maintain instrument qualification, method lifecycle management, and audit readiness.
• Own OOS/OOT investigations from initiation to closure; drive Phase I and Phase II investigations with QA and Manufacturing when needed.
• Author investigation reports documenting hypotheses, evidence, and root causes; defend conclusions to QA and clients.
• Own CAPA for QC‑initiated events; define problems, perform root‑cause analysis, and implement measurable actions.
• Oversee QC method transfers, validations, and VERIFICATIONS to ensure fit‑for‑purpose GMP release and stability testing.
• Serve as QC SME during method troubleshooting and provide guidance to analysts.
• Review and approve analytical methods, specifications, validation protocols and reports; supervise QC documentation.
• Support specification setting and release criteria for new peptide API programs with QA, Regulatory, and client CMC teams.
• Act as primary QC SME and front‑room representative for regulatory inspections and client audits.
• Lead audit and inspection readiness; address findings and ensure remediation is practical and timely.
• Conduct internal QC laboratory audits to identify gaps in execution, documentation, or compliance.

Skills

HPLC/LC-MS/UV

OOS/OOT investigations

GMP/QA collaboration

Empower data system

Strong communication

Leadership experience

Method validation/ transfer

Education

Analytical chemistry degree (B.S./M.S./Ph.D.)

Tools

Empower

ICH Q2(R1)

Job description

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.

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.
• 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.

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.

Equal Opportunity Employer

The company is an equal opportunity employer and is committed to building a diverse and inclusive team. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.