Director, Site Regulatory Compliance Advanced Therapy

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Quality

Quality & Compliance Audit

Professional

Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America

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The Director, Regulatory Compliance is the senior Site-Based Compliance leader responsible for providing independent compliance leadership, maintaining visibility of the site compliance-risk posture, promoting continuous inspection readiness, enabling timely escalation, and strengthening organizational learning at an Advanced Therapy manufacturing site.

The role serves as a strategic compliance partner to Site Leadership, Quality, Manufacturing, MSAT, Engineering, Supply Chain, Regulatory Affairs, and Quality Control. The Director brings an independent regulatory compliance perspective to significant risks and decisions and helps connect site signals to platform and enterprise priorities.

The role requires deep knowledge of advanced therapy manufacturing and the regulatory and operational risks associated with autologous and allogeneic cell therapies, chain of identity, chain of custody, aseptic processing, manufacturing execution systems, cryopreservation, cellular starting materials, and patient-specific manufacturing operations.

As a people leader, the Director builds and develops a high-performing compliance organization and strengthens compliance capability across the site.

The Director enables the site to maintain a sustained state of compliance and inspection readiness by providing proactive and independent compliance leadership, strengthening risk visibility, enabling effective governance and escalation, and fostering prevention, transparency, and continuous improvement.

• Provide strategic site compliance leadership and independent regulatory compliance perspective on site inspection readiness and regulatory risk, product launch readiness and technology transfers, capacity expansion and facility modifications, major deviations, quality events, and data integrity concerns. Provide input on supply continuity risks and enterprise compliance initiatives and potential regulatory reporting events, without assuming formal reportability decision ownership.
• Drive enterprise thinking and organizational capability to connect significant site risks to…