Director of Quality Control (Commercial)

Serán BioScience • Bend, OR

13d • Onsite

About The Position

The Director, Commercial Quality Control leads, oversees, and provides 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 meet 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 laboratories are appropriately staffed, qualified, resourced, and inspection-ready, while promoting data integrity, operational excellence, and continuous improvement. The position develops effective working relationships with internal stakeholders, clients, contract laboratories, equipment service providers, suppliers, and regulatory agencies. It also serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews.

The Director leads and develops the QC organization, sets departmental goals and performance metrics, oversees daily workflow and laboratory capacity, and ensures testing supports manufacturing schedules and customer commitments. The role oversees stability and raw material programs; in-process and manufacturing support; cleaning verification analytical testing; laboratory operations, equipment lifecycle, and vendor relationships; and outsourced laboratory activities. It maintains GMP-compliant laboratory systems and ALCOA+ data integrity practices, leads laboratory investigations and corrective and preventive actions, and partners with Analytical Development and Validation on analytical method lifecycle activities. The Director ensures compliance with applicable FDA, EMA, ICH, USP, and cGMP requirements, supports submissions and agency interactions, and leads continuous improvement initiatives.

The position requires a B.S. or M.S. in chemistry, pharmaceutical sciences, or a related discipline, at least five years of QC management experience, and 10 or more years of GMP experience. Ten or more years of related experience is preferred. CDMO experience is preferred. The role requires expert knowledge of commercial and late-phase GMP QC operations, drug product and raw material release and stability testing, and industry compendia, along with experience with FDA and EU regulatory inspections. The position is based at the company’s corporate headquarters in Bend, Oregon, and requires consistent, predictable in-person attendance. Applicants must be authorized to work in the U.S.; visa sponsorship is not available.

Requirements

• B.S. or M.S. in chemistry, pharmaceutical sciences, or a related discipline.
• At least 5 years of QC management experience.
• 10 or more years of GMP experience.
• Expert knowledge of GMP QC operations for late-phase and commercial programs.
• In-depth understanding and application of cGMP principles, concepts, practices, and standards.
• Experience with regulatory inspections by FDA and EU authorities.
• Expert knowledge of drug product and raw material release and stability testing, industry expectations, methods, and systems for pharmaceutical products.
• Expert knowledge of industry compendia, including USP and Pharm EU.
• Working knowledge of regulatory requirements, including cGMP, FDA/EU, ICH, and USP.
• Demonstrated continued growth and responsibility in management and leadership experience, with proven ability to lead organizations.
• Ability to influence diverse stakeholders, drive cross-functional accountability and decision-making, and partner with other functional groups to achieve business objectives.
• Ability to organize and manage work independently with minimal oversight.
• Time and project management skills, including ability to multitask and meet deadlines.
• Excellent verbal and written communication skills; ability to maintain productive relationships with coworkers, clients, and external contacts.
• Excellent organizational skills and attention to detail.
• Ability to accept feedback from varied sources and constructively manage conflict.
• Strong analytical and problem-solving skills.
• Ability to prioritize tasks and delegate when appropriate.
• Proficiency with Microsoft Office Suite or related software.
• Must be able to lift up to 15 pounds at a time.
• Must be authorized to work for an employer in the U.S.; the company is unable to sponsor or take over sponsorship of an employment visa.

Nice To Haves

• 10 or more years of related experience.
• CDMO experience.
• General knowledge of oral solid dosage manufacturing processes.
• Interest in developing and implementing new technologies.

Responsibilities

• Lead, develop, mentor, coach, and evaluate Quality Control staff; maintain appropriate training and GMP qualifications and address employee discipline in accordance with company policy.
• Establish departmental goals aligned with organizational quality and operational objectives, foster quality ownership and continuous improvement, and oversee daily departmental workflow.
• Lead QC activities supporting commercial and late-stage clinical manufacturing and ensure timely, compliant release testing for raw materials, intermediates, bulk products, and finished drug products.
• Ensure laboratory testing supports manufacturing schedules and customer commitments; plan capacity and resources and monitor departmental performance metrics and KPIs.
• Oversee commercial and late-phase clinical stability programs, including protocol execution, review and approval of data and trending reports, investigation outcomes, and timely reporting of results and quality concerns.
• Direct raw material testing, qualification, sampling, release controls, and disposition; collaborate with Supply Chain and Supplier Quality on material quality issues and support supplier qualification and material risk assessments.
• Provide timely in-process testing and partner with Manufacturing and Process Sciences on process monitoring and continued process verification; support PPQ campaigns and commercial validation through laboratory testing.
• Oversee analytical support for equipment cleaning verification, including swab and rinse testing under approved procedures and validated methods; support cleaning validation and continued verification strategies with Manufacturing, Validation, and Quality Assurance.
• Direct laboratory scheduling, workflow, and capacity planning; oversee instrumentation lifecycle management, calibration, qualification, maintenance, repair, and replacement; manage equipment and service vendors and coordinate instrument service schedules.
• Ensure laboratory facilities remain compliant and inspection-ready.
• Own external laboratory relationships, oversee analytical testing agreements and outsourced testing, monitor performance and service quality, and ensure appropriate review and disposition of externally generated data.
• Maintain GMP-compliant laboratory systems and ALCOA+ data integrity practices; support audits and inspections; lead investigations of OOS, OOT, atypical results, laboratory deviations, and data events; drive timely corrective and preventive actions.
• Partner with Analytical Development and Validation on method transfer, qualification, verification, and validation; ensure control strategies, specifications, and analytical procedures remain fit for intended use; support compendial assessments and implementation of pharmacopeial requirements.
• Ensure compliance with applicable FDA, EMA, ICH, USP, and cGMP requirements; support regulatory submissions and agency interactions; participate in Management Review and Quality Council initiatives.
• Lead continuous improvement initiatives to enhance laboratory effectiveness and compliance robustness.
• Organize and manage responsibilities independently, prioritize and delegate tasks as appropriate, meet deadlines, and communicate effectively with coworkers, clients, and external contacts.
• Adhere to consistent and predictable in-person attendance.

Benefits

• Over four weeks of paid time off accrued annually.
• Employer contributions to a retirement account begin after 90 days; no employee match or vesting period is required.
• Multiple health plan options 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