Senior Director, IT Compliance & Governance (Contractor)
Confidential
Senior Director, IT Compliance & Governance (Contractor)
About the Company
Innovative company designing & developing gene therapeutic products
Industry
Biotechnology
Type
Public Company
Founded
2013
Employees
51-200
Categories
- Biotechnology
- Healthcare
- Pharmaceuticals
- Genetics
Specialties
- gene therapy
- adeno-associated virus
- biotechnology
- rare diseases
- clinical
- lab
- clinical trials
- and science
- science
- retina
- cystic fibrosis
- genetic medicine
- and ophthalmology
Business Classifications
- B2B
About the Role
The 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
Functions
- Information Technology
- Operations
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