Director of Quality Control (Commercial)

Your tasks

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.

Requirements

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.

Other

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