Interim Senior Director, IT Compliance & Governance (Contractor)
confidentialSan Jose, CA
Interim Senior Director, IT Compliance & Governance (Contractor)
confidentialSan Jose, CAManager L7
Research and Development in BiotechnologyBiological Product ManufacturingPharmaceutical Preparation Manufacturing
APPLY NOW (opens in a new tab)Interim Senior Director, IT Compliance & Governance (Contractor)
About the Company:
- Innovative company designing & developing gene therapeutic products
- IndustryBiotechnologyTypePublic Company
- Founded2013Employees51-200 Categories
- BiotechnologyHealthcarePharmaceuticalsGeneticsSpecialtiesgene therapyadeno-associated virusbiotechnologyrare diseasesclinicallabclinical trialsand sciencescienceretinacystic fibrosisgenetic medicineand ophthalmology
Business ClassificationsB2BAbout the RoleThe Company is seeking a Senior Director for IT Compliance and Governance. The successful candidate will be responsible for the operational management of GxP Compliance Audit and Supplier Quality Management Programs. This includes coordinating and managing various types of audits, ensuring the accuracy and compliance of audit deliverables, and maintaining the Approved GxP Supplier List.
The role also involves developing and reporting on audit and supplier quality metrics, as well as supporting a quality-focused work environment that encourages continuous improvement and collaboration. Applicants must have a B.S./B.A. in a science or related life science field, with an advanced scientific degree preferred, and at least 8 years of experience in a regulated environment within the biotech or similar industry. A minimum of 3 years in a role with GxP QA oversight is required.
The ideal candidate will have a proven track record in GxP Quality Management Systems, QA audit support, and a deep understanding of GMP and GCP requirements for investigational products. Excellent communication, interpersonal skills, and the ability to thrive in a fast-paced, small company environment are essential. The role demands a collaborative approach, the ability to work with minimal direction, and a commitment to fostering a culture of learning, respect, and teamwork.
Hiring Manager Title
Director, Quality Systems
FunctionsInformation Technology
Operations
Matching similar jobs
Level
Manager L7
Location
San Jose, CA
Occupation
Compliance Managers
Industry
Research and Development in Biotechnology
Posted
today