Director of Regulatory QA

We are seeking a dynamic and experienced Sr. Director / Director of Regulatory & Quality Assurance to lead and oversee the strategic direction of our Quality Assurance, Quality Engineering, Metrology, Document Control and Training functions within a fast-paced pharmaceutical contract research organization (CRO).  This role is responsible for guiding a team of functional managers to ensure regulatory compliance, operational excellence, and client satisfaction across all phases of drug development and testing.

The ideal candidate will bring a strategic mindset, strong leadership capabilities, and a collaborative approach to drive continuous improvement and regulatory alignment across the organization. This is a high-impact role for a leader who thrives in a mission-driven, science-based environment.

Key Responsibilities

Regulatory Affairs Leadership

• Develop and maintain regulatory strategies, policies, and procedures to ensure compliance with FDA, EMA, ICH, and other global regulatory bodies.

• Oversee regulatory submissions in collaboration with clients and internal stakeholders.

• Ensure regulatory compliance in product labeling, advertising, and promotional materials.

• Serve as the primary liaison with regulatory agencies and clients on compliance matters.

• Support audits and inspections, including FDA, sponsor, and third-party audits.

Functional Oversight & Team Leadership

• Provide strategic leadership to managers overseeing Quality Assurance, Quality Engineering, Metrology, Document Control, and Training.

• Ensure alignment of departmental goals with organizational objectives and regulatory expectations.

• Mentor and develop managerial staff to foster leadership growth and operational excellence.

• Promote cross-functional collaboration and accountability across quality and regulatory teams.

Quality Assurance & Quality Engineering

• Guide the development and maintenance of the Quality Management System (QMS).

• Ensure compliance with cGMP, GLP, and GCP standards across all testing and manufacturing activities.

• Oversee audit readiness, CAPA programs, deviation investigations, and change control processes.

• Drive continuous improvement initiatives and risk-based quality strategies.

Metrology & Equipment Qualification

• Ensure proper calibration, maintenance, and qualification of laboratory and manufacturing equipment.

• Oversee metrology systems to meet regulatory and operational requirements.

• Collaborate with engineering and validation teams to support equipment lifecycle management.

Training & Compliance

• Oversee the development and execution of a comprehensive training program to ensure staff competency and regulatory readiness.

• Monitor training effectiveness and compliance across departments.

• Foster a culture of quality, accountability, and continuous learning.

Strategic Leadership & Client Engagement

• Partner with business development and operations to support client onboarding, audits, and project execution.

• Provide regulatory and quality guidance during proposal development and project planning.

Contribute to strategy and client value proposition through quality and compliance excellence.