Manager, CMC Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide quality oversight for vendors to ensure that drug substances, drug products, and finished products are manufactured, tested, released, and distributed in accordance with cGMP standards.

• Lead the review of batch records and the disposition of clinical lots for drug substances, inhaled products, and clinical packaging and labeling.

• Assist with QP certification and release processes at contract manufacturing partners for international clinical trials.

• Prepare batch documentation packages and coordinate release schedules with CMOs, Supply Chain, and Clinical Operations.

• Review executed batch records, certificates of analysis, and testing data for precision, completeness, and compliance.

• Facilitate the resolution of documentation discrepancies and gaps.

• Supervise GMP Quality Systems activities at external partners, including deviations, investigations, CAPAs, change controls, and OOS/OOT investigations.

• Maintain tracking and metrics for disposition and batch reviews.

• Communicate product quality performance and release status to Quality and cross-functional teams.

• Collaborate with CMC, Supply Chain, and Regulatory Affairs regarding product quality impacts, risks, and mitigation strategies.

• Review and provide quality insights on batch records, specifications, test methods, protocols, reports, and SOPs.

• Assist with batch release and disposition procedures.

• Support activities related to regulatory inspection preparation and readiness.

⛳️ Requirements

• BA/BS degree in Chemistry, Biology, or Life Sciences.

• A minimum of 4 years of experience in the pharmaceutical industry, with a focus on GMP quality assurance.

• Proven knowledge of Quality Systems and cGMP within a regulated environment.

• Hands-on experience with batch record review and product release/disposition for clinical or commercial pharmaceutical products.

• Familiarity with Good Distribution Practices and international clinical supply requirements, including EU Annex 13 and QP release is preferred.

• Experience with deviation management, investigations, CAPA, change control, and OOS/OOT processes at CMOs.

• Knowledge of inhaled drug products, drug substances, and/or clinical packaging and labeling operations is preferred.

• Auditing experience is preferred.

• Strong attention to detail and analytical abilities, with a capacity for risk-based decision-making.

• Excellent interpersonal skills with the ability to influence and establish rapport across functions and with external partners.

• Exceptional organizational and time management skills; adept at managing multiple concurrent batches and tight release schedules.

• Outstanding verbal and written communication skills.

• Experience in dynamic, start-up environments is preferred.

• Capability to work under pressure and adapt to changing priorities and tight deadlines.

🏝️ Benefits

• Equal employment opportunities and nondiscrimination protections.

• No unsolicited resumes or agency outreach accepted.