Manager, Quality Operations – CMC

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

📋 Description

• Oversee comprehensive Product Quality for designated clinical and commercial programs, encompassing drug substance, drug product, reference standards, packaging, labeling, serialization, and related contract service providers.

• Evaluate and authorize critical product and process documents, including specifications, batch records, technical transfer documents, validation protocols and reports, stability documentation, and quality agreements.

• Guide the evaluation and resolution of deviations, out-of-specification/out-of-trend results, temperature excursions, change controls, corrective and preventive actions (CAPAs), and product quality complaints; collaborate with relevant subject matter experts to make informed, timely, risk-based decisions.

• Provide Quality oversight for contract manufacturers, laboratories, and other service providers, including vendor qualification, auditing, performance monitoring, manufacturing record evaluations, issue resolution, and follow-up on observations and commitments.

• Lead or assist in product disposition activities for clinical and commercial batches, including decisions on release or rejection and coordination with Qualified Persons where necessary.

• Act as the Product Quality representative on CMC, program, and external partner teams, delivering strategic Quality insights into product development, control strategy, technology transfer, process validation, stability, regulatory submissions, and commercialization.

• Collaborate with CMC, Regulatory Affairs, Supply Chain, and external entities to foresee and mitigate quality risks, support IND/NDA submissions and regulatory inspections, and establish scalable processes that ensure inspection readiness, launch readiness, and consistent supply to patients.

⛳️ Requirements

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Engineering, Biology, or a related scientific discipline.

• A minimum of 6 years of progressive experience in a GMP-regulated setting supporting clinical and/or commercial pharmaceutical products.

• Robust understanding of GMP requirements and relevant FDA, EMA, ICH, and other global regulatory expectations, with a proven ability to translate these requirements into practical, risk-based decisions.

• Experience in supporting the manufacturing of small-molecule drug substances and solid oral drug products, including Quality Management Systems, QC operations, technical transfer, validation, stability, and product lifecycle management.

• Practical experience with batch disposition, deviations and investigations, change control, CAPA, out-of-specification/out-of-trend events, product complaints, and interactions with external manufacturing partners.

• Familiarity with supporting health authority inspections, pre-approval inspections, internal audits, and/or external supplier audits.

• Willingness to travel domestically and internationally based on program requirements, estimated at around 15–20%.

• Regular use of computers, devices, or other office equipment, clear communication skills, occasional physical movement, comfort with screen-based work, basic manual coordination, and focus.

• Reasonable accommodations may be provided to enable individuals with disabilities to perform these functions.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health insurance plans.

• Opportunities for professional development and career advancement.

• Flexible work arrangements and a supportive work environment.