The Director, Commercial Quality Control is responsible for leadership, oversight, and strategic direction of Quality Control operations supporting commercial and late-stage clinical manufacturing. The role ensures that laboratory activities, analytical testing programs, personnel, systems, and facilities are compliant with applicable regulatory requirements and capable of supporting commercial product release, raw material disposition, stability programs, in-process testing, cleaning verification activities, and continued process verification initiatives. This role is responsible for ensuring that Quality Control laboratories are appropriately staffed, qualified, resourced, and inspection-ready while maintaining a strong culture of data integrity, operational excellence, and continuous improvement. This position establishes and maintains effective working relationships with internal stakeholders, clients, contract laboratories, equipment service providers, suppliers, and regulatory agencies. The Director of Commercial Quality Control also serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to quality control.
Leader Responsibilities- Leads and develops a high-performing Quality Control organization
- Provides mentoring, coaching, and professional development for technical staff; provides constructive and timely performance evaluations, and handles discipline of employees in accordance with company policy
- Establish clear departmental goals aligned with organizational quality and operational objectives
- Conducts performance reviews and ensure staff maintain appropriate training and GMP qualifications
- Fosters a culture of quality ownership, compliance, and continuous improvement
- Oversees daily workflow of the department
Commercial Quality Control Operations- Lead Quality Control activities supporting commercial and late-stage clinical manufacturing.
- Ensure timely and compliant release testing of raw materials, intermediates, bulk products, and finished drug products.
- Ensure laboratory activities support manufacturing schedules and customer commitments.
- Maintain laboratory capacity planning and resource forecasting to support business growth.
- Establish and monitor departmental performance metrics and key performance indicators.
Stability Program Management- Oversee commercial and late phase clinical stability programs.
- Ensure ongoing stability commitments are executed according to approved protocols.
- Review and approve stability data, trending reports, and investigation outcomes.
- Ensure timely reporting of stability results and product quality concerns.
Raw Material Program- Direct raw material testing, qualification, and disposition activities.
- Ensure appropriate sampling, testing, and release controls are maintained.
- Collaborate with Supply Chain and Supplier Quality functions regarding material quality issues.
- Support supplier qualification and material risk assessment activities.
In-Process Testing & Manufacturing Support- Ensure timely in-process testing support for manufacturing operations.
- Partner with Manufacturing and Process Sciences teams to support process monitoring and continued process verification.
- Support PPQ campaigns and commercial validation activities through laboratory testing services.
Cleaning Verification Program- Oversee analytical support for equipment cleaning verification programs.
- Ensure cleaning verification swab and rinse testing is performed according to approved procedures and validated analytical methodologies.
- Support cleaning validation and continued cleaning verification strategies.
- Collaborate with Manufacturing, Validation, and Quality Assurance regarding cleaning program effectiveness and compliance.
Laboratory Operations & Asset Management- Direct laboratory operations including scheduling, workflow management, and capacity planning.
- Oversee laboratory instrumentation lifecycle management.
- Ensure timely calibration, qualification, maintenance, repair, and replacement of laboratory equipment.
- Manage vendor relationships supporting laboratory equipment and services.
- Coordinate instrument service schedules to minimize operational disruptions.
- Ensure laboratory facilities remain inspection-ready and compliant.
Contract Laboratory Oversight- Serve as Quality Control owner for external laboratory relationships.
- Oversee analytical testing agreements and outsourced testing activities.
- Monitor laboratory performance metrics and service quality.
- Ensure appropriate data review and disposition of externally generated data.
Laboratory Compliance & Data Integrity- Maintain GMP-compliant laboratory systems and practices.
- Ensure data integrity principles are implemented and maintained in accordance with ALCOA+ requirements.
- Support internal audits, client audits, and regulatory inspections.
- Lead laboratory investigation activities related to OOS, OOT, atypical results, laboratory deviations, and data events.
- Drive timely and effective corrective and preventive actions.
Method Lifecycle Management- Partner with Analytical Development and Validation teams to support method transfer, qualification, verification, and validation activities.
- Ensure control strategies, specifications, and analytical procedures remain fit for intended use throughout the product lifecycle.
- Support compendial assessments and implementation of evolving pharmacopeial requirements.
Quality Systems & Regulatory Compliance- Ensure compliance with applicable FDA, EMA, ICH, USP, and cGMP requirements.
- Maintain inspection readiness across all laboratory operations.
- Support regulatory submissions and agency interactions as required.
- Participate in Management Review and Quality Council initiatives.
- Lead continuous improvement initiatives to enhance laboratory effectiveness and compliance robustness.
Required Skills & Abilities- General knowledge of oral solid dosage manufacturing processes preferred
- 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 the FDA and EU authorities
- Ability to influence diverse stakeholders and drive accountability and decision-making cross functionally
- Interest in developing and implementing new technologies.
- Demonstrated ability to partner with other functional groups to achieve business objectives
- Experience organizing and managing work responsibilities while working independently with minimal oversight
- Time and project management skills with the ability to multi-task and meet deadlines
- Excellent verbal and written communication skills
- Excellent organizational skills and attention to detail
- Communicate effectively and maintain productive relationships with coworkers, clients, and other contacts outside of the company
- Accepts feedback from a variety of sources and constructively manages conflict
- Strong analytical and problem-solving skills
- Proven ability to lead organizations
- Ability to prioritize tasks and to delegate when appropriate
- Proficient with Microsoft Office Suite or related software.
Education & Experience- B.S. / M.S. in chemistry, pharmaceutical sciences, or related discipline with at least 5 years QC management experience and 10+ years related experience preferred (CDMO experience preferred)
- Demonstrated continued growth and responsibility in management and leadership experience.
- Expert level knowledge of drug product and raw material release and stability testing, industry expectations, methods, and systems for pharmaceutical products.
- Expert level knowledge of Industry Compendia (USP/Pharm EU, etc.).
- Working knowledge of regulatory requirements including cGMP, FDA/EU, ICH and USP.
- Requires 10+ years of GMP experience.
Physical Requirements- Prolonged periods of sitting or standing at a desk and working on a computer.
- Must be able to lift up to 15 pounds at a time
- Adheres to consistent and predictable in-person attendance
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees' wellbeing, along with access to pet insurance.
The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701
