Director of Cranbury GMP Compliance

Job Title: Director, GMP Technical Operations & Readiness

Location: Cranbury, NJ, USA
Department: US GMP Operations
Reports to: Head of US GMP Operations

Position Summary

The Director, GMP Technical Operations & Readiness provides scientific, technical, and GMP leadership supporting biologics Manufacturing and Quality Control operations at the Cranbury site.

This role works closely with Manufacturing, QC, Engineering, QA, MSAT, Validation, Project Management, clients, and external partners to resolve complex technical issues, support technology transfer and validation activities, strengthen GMP compliance, and prepare the site and client programs for regulatory inspections and commercial manufacturing.

Key Responsibilities

• Provide scientific and technical leadership supporting GMP Manufacturing and QC operations, including analytical controls, product quality, troubleshooting, and operational readiness.


• Partner with Manufacturing, QC, Engineering, QA, MSAT, and Validation to assess technical and GMP risks, resolve complex issues, and support continuous improvement.


• Work with clients and internal SMEs to conduct PLI and regulatory inspection gap assessments, identify readiness risks, develop action plans, and support inspection preparation.


• Support client audits and regulatory inspections through readiness assessments, facility and operational walkthroughs, SME preparation, documentation review, and technical responses.


• Provide practical guidance to Manufacturing and QC teams on GMP compliance, investigations, documentation practices, data integrity, and regulatory expectations.


• Support analytical method lifecycle, technology transfer, equipment/process validation, PPQ, and commercial manufacturing readiness activities.


• Support manufacturing and laboratory investigations, deviations, OOS/OOT events, process changes, comparability assessments, and other technical issues in collaboration with QA and functional SMEs.


• Provide technical oversight of external laboratories, CROs, CDMOs, and vendors, and contribute technical expertise to CMC documentation, regulatory submissions, and client communications.

Qualifications

• BS, MS, or PhD in a relevant scientific or engineering discipline.


• 12+ years of experience in biologics, pharmaceutical manufacturing, QC, Analytical Development, CMC, or Technical Operations.


• 5+ years of leadership or management experience.


• Strong experience supporting GMP biologics Manufacturing and/or QC operations.


• Experience working cross-functionally with Manufacturing, QC, Engineering, QA, and Validation.


• Experience supporting regulatory inspections, client audits, GMP gap assessments, or inspection readiness activities.


• Experience with analytical lifecycle management, technology transfer, validation, PPQ, or commercial manufacturing readiness.


• Experience working with clients, CROs, CDMOs, contract laboratories, or other external partners.


• PLI/PAI readiness experience preferred.

Key Competencies

• Strong scientific and technical judgment


• Practical understanding of GMP operations


• Cross-functional collaboration and influencing skills


• Client-facing and inspection-readiness capabilities


• Strong problem-solving and risk-assessment skills


• Excellent communication and leadership skills

The anticipated salary range for this position is $134,400 to $228,500

Job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability