Director of Operations

Job Title: Director of Operations

Work Location: Norfolk County, Massachusetts

Summary:

Seeking an experienced operations leader to oversee multidisciplinary teams, ensure regulatory compliance, and drive operational excellence within the life sciences sector. This role requires expertise in GxP environments, strong leadership skills, and the ability to support business development initiatives.

Responsibilities:

• Lead and mentor a diverse team of consultants, engineers, project managers, and field service staff, focusing on operational performance and staff development.
• Drive the implementation of standard operating procedures and foster a culture of accountability and continuous improvement.
• Act as the senior subject matter expert on GxP compliance, advising on facility design, qualification, and ongoing regulatory strategies.
• Interpret and apply regulatory standards such as FDA GMPs, USP, ICH, ISO, and DEA across a variety of client projects.
• Oversee the creation and execution of compliance deliverables, including risk assessments, validation plans, and inspection readiness documentation.
• Coordinate service delivery across consulting, project management, CQV, calibration, environmental monitoring, and certification functions.
• Collaborate with technology teams to implement SaaS solutions for asset management and compliance operations.
• Support business development efforts by serving as a technical resource in client engagements, proposals, and industry events.

Qualifications:

• 10 years of experience in GxP-regulated life sciences, including biotech, pharma, cell & gene therapy, sterile/aseptic operations, or related fields.
• Minimum 5 years in a leadership role managing technical or cross-functional teams.
• Extensive practical knowledge of GMP with proven experience in inspection readiness, remediation, or facility start-up.
• Experience managing teams delivering consulting, CQV, facility, or compliance services, either internally or as an outsourced provider.
• Strong communication skills for conveying complex regulatory and technical concepts to both technical and executive audiences.
• Background in multiple service domains such as GxP compliance consulting, facility design/engineering, CQV, calibration, environmental monitoring, certification, or compliance SaaS (preferred).
• Experience supporting sales or account growth as a technical subject matter expert or solutions architect (preferred).
• Familiarity with the regional life sciences ecosystem and specialized facility requirements (preferred).