Associate Director, GxP Compliance
- $1B Pharmaceutical Company
- Highly visible role with growth opportunity
A rapidly expanding mid-sized pharmaceutical company is seeking an expert in GxP compliance to join its growing team. This company is a leader in a niche sector of the pharmaceutical world, and is driving the industry standard for exceptional products.
The incumbent will be responsible for continuous improvement of GxP Systems used for the production and support of a major high-volume facility. The working atmosphere will involve a multitude of exciting projects and cross-functional tasks with various stakeholders. This role will also be the face of the company when facing the FDA in various capacities
Responsibilities:
- Liase directly with Senior Leadership team on strategic oversight over the QMS
- Collaborate with System Owner to provide inspection readiness counsel and audit support
- Lead architect in developing department SOPs and provide SOP review for new systems
- Perform scheduled reviews of existing GxP systems and delineate remediation plans for non-conformances
- Annual product reviews, quality agreements, responding to FDA as required
Qualifications:
- 8 years experience in Quality Compliance in the pharma / biotech / device industry
- Strong communication skills and leadership capabilities
