Director / Sr. Director, Quality Compliance

ABOUT US

We are seeking a Senior Director, Quality Compliance will lead and oversee the compliance function within the Quality organization, ensuring that all commercial operations-including manufacturing, supply chain, distribution, and post-market activities-adhere to applicable global regulatory requirements and internal standards. Your role will be responsible for building and sustaining a culture of quality, integrity, and compliance across the organization. You bring deep expertise in GxP regulations, a strong background in commercial biotech operations, and the ability to partner cross-functionally to drive operational excellence. This is a full-time hybrid position (3 days a week) in our Somerville - Assembly Row, Massachusetts office.

RESPONSIBILITIES

• Provide compliance support for all programs (commercial and clinical)
• Execute on critical compliance escalations, risks and events (Risk register, BPDR, recalls, complaints)
• Manage Audit program including self-inspection and R&D
• Third party qualification includes external audits, initial qualification and monitoring / requalification on periodic frequency.
• Foundational compliance for bbb including QMS oversight, document control, record retention and training
• Ensure inspection readiness at all times and support partner inspection readiness activities as needed.
• Provide strategic leadership for Quality Compliance across global commercial operations.
• Develop, implement, and maintain the company's quality compliance programs, policies, and procedures in alignment with FDA, EMA, ICH, and other applicable regulatory requirements.
• Serve as a key member of the Quality Leadership Team, influencing strategy, governance, and resource planning.

QUALIFICATIONS

• Bachelor's degree in life sciences, engineering, or related field required; advanced degree preferred.
• 12+ years of progressive experience in Quality and Compliance within the biopharmaceutical industry, with at least 5 years in a senior leadership role.
• Deep knowledge of GxP regulations (GMP, GDP, GLP, GCP) applicable to commercial biotech operations.
• Proven track record in leading regulatory inspections (FDA, EMA, MHRA, etc.) with successful outcomes.
• Experience building and scaling global quality compliance systems and programs.
• Strong collaboration and influencing skills across diverse functions and levels of the organization.
• Exceptional judgment, integrity, and ability to make risk-based decisions in a fast-paced environment.
• Excellent communication, leadership, and presentation skills.