Associate Director, Quality Control

Role Summary

We are seeking an experienced Associate Director Quality Control to lead analytical laboratory operations supporting pharmaceutical manufacturing and product development. The ideal candidate is a proactive leader with strong technical expertise, comprehensive understanding of industry practices, regulatory requirements, and a commitment to safety, quality and continuous improvement. This position is based in Massachusetts and requires a presence on-site three days per week.

Responsibilities

• Develop and execute strategic plans for the QC function, leveraging expertise to drive decisions that align with business objectives.
• Manage departmental goals to ensure reliable product supply, adherence to company policies, and successful project execution.
• Oversee budgeting, scheduling, and performance standards to support operational efficiency and compliance.
• Ensure all aspects of laboratory operations are effectively managed, including training, scheduling, inventory, equipment maintenance/calibration, and safety.
• Maintain validated methods and qualified equipment, ensuring all QC testing and data management activities comply with SOPs, cGMPs, and regulatory standards.
• Monitor performance metrics and trends to identify opportunities for improvement.
• Ensure effective use of electronic systems such as ERP, QMS, LIMS, and lab equipment software.
• Serve as system administrator or alarm notification contact for area-specific software and monitoring systems.
• Build and manage a high-performing team through effective staffing, training, performance reviews, and workload balancing.
• Foster a culture of continuous improvement, compliance, and technical excellence.
• Develop and implement employee development plans to enhance skills, support succession planning, and mitigate operational risks.
• Act as a liaison with other departments and management levels to support operational decisions and strategic planning.
• Lead team meetings, facilitate VPM efforts, participate in GEMBA walks, and apply Lean/Project Management tools.
• Establish and interpret operating policies and procedures for the QC function.
• Ensure inspection readiness and compliance with global regulatory requirements (e.g., FDA, USP/EP/JP).
• Interface with regulatory inspectors and internal auditors, ensuring timely resolution of commitments.
• Oversee timely and effective use of QMS tools including training, investigations, deviations, CAPAs, SOP revisions, change controls, and protocols.
• Serve as lead investigator, SOP owner, change control author, or protocol study lead as needed.
• Resolve complex technical and compliance issues independently, leveraging internal and external expertise.
• Promote and enforce safety protocols, ensuring proper use of protective equipment and safe handling of hazardous materials.
• Proactively identify and address safety and environmental risks within the laboratory environment.

Qualifications

• 10 years‚Äô experience with a BS of progressively more responsible laboratory management in a related scientific/technical discipline or equivalent combination of education and relevant experience in the pharmaceutical industry, related GMP environment, or equivalent.
• Deep understanding of QC operations, regulatory requirements, and industry best practices with proven leadership in managing complex laboratory environments and cross-functional teams.
• Recognized as a subject matter expert within the organization, with the ability to solve advanced problems and guide others.
• Flexibility with scheduling requirements for staff and manage support to include evenings, weekends, shifts, and holiday coverage, including during adverse weather conditions.
• Ability to manage and direct staff who work with potentially hazardous chemical, radiological, and/or biological materials and who must be able to lift/move a variety of materials.

Skills

• Leadership and people management
• Regulatory knowledge (FDA, GMP, cGMP, USP/EP/JP)
• Quality systems and data integrity
• Lean/Project Management tools
• Laboratory operations management
• Technical problem solving and decision making

Education

• Bachelor‚Äôs degree in a related scientific/technical discipline required; advanced degree preferred

Additional Requirements

• On-site presence three days per week in Massachusetts