Director of Quality Control (Commercial)

Serán BioScience • Bend, OR

19d • Onsite

About The Position

The Director, Commercial Quality Control provides leadership, oversight, and strategic direction for Quality Control operations supporting commercial and late-stage clinical manufacturing. The role ensures laboratory activities, analytical testing programs, personnel, systems, and facilities comply with applicable regulatory requirements and support commercial product release, raw material disposition, stability programs, in-process testing, cleaning verification, and continued process verification. The Director ensures Quality Control laboratories are appropriately staffed, qualified, resourced, and inspection-ready while fostering data integrity, operational excellence, and continuous improvement.

The role builds effective working relationships with internal stakeholders, clients, contract laboratories, equipment service providers, suppliers, and regulatory agencies. It serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and leads improvement initiatives across Quality Control.

The Director leads and develops the Quality Control organization; oversees daily department workflow and commercial laboratory operations; manages stability, raw material, in-process, and cleaning verification programs; and oversees laboratory assets, facilities, and external laboratory relationships. The position maintains GMP-compliant laboratory systems and data integrity, leads laboratory investigations and corrective and preventive actions, supports analytical method lifecycle activities, and ensures compliance with applicable FDA, EMA, ICH, USP, and cGMP requirements.

Requirements

• B.S. or M.S. in chemistry, pharmaceutical sciences, or a related discipline.
• At least 5 years of QC management experience and 10 or more years of related experience are preferred.
• At least 10 years of GMP experience.
• Demonstrated continued growth and responsibility in management and leadership experience, including proven ability to lead organizations.
• Expert knowledge of GMP Quality Control operations for late-phase and commercial programs.
• Expert knowledge of drug product and raw material release and stability testing, industry expectations, methods, and systems for pharmaceutical products.
• In-depth understanding and application of cGMP principles, concepts, practices, and standards.
• Experience with regulatory inspections by the FDA and EU authorities.
• Expert knowledge of industry compendia, including USP and Pharm. Eur.
• Working knowledge of regulatory requirements, including cGMP, FDA/EU, ICH, and USP.
• Ability to influence diverse stakeholders, drive cross-functional accountability and decision-making, and partner with other functions to achieve business objectives.
• Ability to organize and manage responsibilities independently with minimal oversight; strong time and project management skills and ability to multitask and meet deadlines.
• Excellent verbal and written communication, organizational, and attention-to-detail skills.
• Ability to communicate effectively and maintain productive relationships with coworkers, clients, and external contacts.
• Ability to accept feedback from varied sources and constructively manage conflict.
• Strong analytical and problem-solving skills; ability to prioritize and delegate tasks appropriately.
• Proficiency with Microsoft Office Suite or related software.
• Must be able to meet consistent and predictable in-person attendance requirements.
• Applicants must be authorized to work for an employer in the U.S.; the employer is unable to sponsor or take over sponsorship of an employment visa.

Nice To Haves

• General knowledge of oral solid dosage manufacturing processes.
• CDMO experience.
• Interest in developing and implementing new technologies.

Responsibilities

• Lead, develop, mentor, and coach Quality Control staff; provide performance evaluations, manage discipline in accordance with company policy, and ensure training and GMP qualifications are maintained.
• Establish departmental goals aligned with organizational quality and operational objectives, foster quality ownership and continuous improvement, and oversee daily departmental workflow.
• Lead Quality Control activities supporting commercial and late-stage clinical manufacturing, including timely release testing of raw materials, intermediates, bulk products, and finished drug products.
• Ensure laboratory activities support manufacturing schedules and customer commitments; plan laboratory capacity and resources; and establish and monitor performance metrics and key performance indicators.
• Oversee commercial and late-stage clinical stability programs, including execution of approved protocols, review and approval of data and trending reports, investigation outcomes, and timely reporting of results and product quality concerns.
• Direct raw material testing, qualification, sampling, and disposition; collaborate with Supply Chain and Supplier Quality on material quality issues; and support supplier qualification and material risk assessment.
• Ensure timely in-process testing support for manufacturing, partner with Manufacturing and Process Sciences on process monitoring and continued process verification, and support PPQ campaigns and commercial validation activities.
• Oversee analytical support for equipment cleaning verification; ensure swab and rinse testing follows approved procedures and validated methods; support cleaning validation and continued verification strategies; and collaborate on program effectiveness and compliance.
• Direct laboratory scheduling, workflow, and capacity planning; oversee the laboratory instrumentation lifecycle; ensure equipment calibration, qualification, maintenance, repair, and replacement; manage equipment and service vendors; coordinate service schedules; and maintain inspection-ready, compliant facilities.
• Serve as Quality Control owner for external laboratory relationships; oversee analytical testing agreements and outsourced testing; monitor performance and service quality; and ensure appropriate review and disposition of external data.
• Maintain GMP-compliant laboratory systems and practices and implement and maintain data integrity principles in accordance with ALCOA+ requirements.
• Support internal audits, client audits, and regulatory inspections; lead investigations into OOS, OOT, atypical results, laboratory deviations, and data events; and drive timely, effective corrective and preventive actions.
• Partner with Analytical Development and Validation teams on method transfer, qualification, verification, and validation; ensure control strategies, specifications, and procedures remain fit for intended use; and support compendial assessments and implementation of pharmacopeial requirements.
• Ensure compliance with applicable FDA, EMA, ICH, USP, and cGMP requirements; maintain laboratory inspection readiness; support regulatory submissions and agency interactions; participate in Management Review and Quality Council initiatives; and lead continuous improvement initiatives.

Benefits

• Over four weeks of paid time off accrued annually.
• Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period.
• Various health plans with minimal employee contributions.
• Basic life and long-term disability coverage, with the option to increase or add coverage.
• Employee Assistance Program supporting employee wellbeing.
• Access to pet insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Director