Director of Quality Control (Commercial)

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