Associate Director, Computer Systems Validation

About the position

The Associate Director, Computer Systems Validation (CSV), Equipment Commissioning & Qualification (ECQ) supports the activities and personnel associated with design, development, delivery, validation, maintenance and support of GMP computerized systems at multi-use sites through interaction with internal team members and peer-level customers as well as external service providers. The individual supports multiple projects and ongoing work activities of low to moderate complexity to ensure compliance to regulatory requirements. The individual directly supervises contract and/or full-time staff to facilitate the completion of departmental deliverables. The incumbent is responsible to author, maintain and manage the System Development Life Cycle for Qualification of Equipment and Validation of Systems. The incumbent will provide direct leadership and oversight over the Compliance Team responsible for the Historical Performance Review.

Responsibilities

• Expert knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
• Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
• Ability to develop, delegate and motivate others including direct and indirect reports.
• Advanced understanding of change controls, investigations, deviations and CAPA management in a regulated pharmaceutical industry.
• Strong multi-tasking ability. Ability to effectively manage multiple CSV projects, initiatives and activities simultaneously. Excels at meeting objective-oriented schedules and timelines.
• Strong written and verbal communication skills.
• Excellent interpersonal skills with experience dealing with a diverse workforce.
• Strong presentation development and delivery skills.
• Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook with extensive background in database systems.
• Ability to create and analyze meaningful metrics.

Requirements

• BS in Computer Engineering or Computer Science related discipline preferred.
• Minimum of 10 years' experience in a cGMP environment in the pharmaceutical industry.
• Minimum of 8 years' experience performing/supporting pharmaceutical computer systems validation on pharmaceutical equipment or equipment systems.
• Minimum of 7 years' experience with direct people leadership.
• Minimum of 8 years' experience interacting with regulatory agents, external and/or internal auditors in a compliance audit environment.

Benefits

• Competitive benefits, services and programs that provide resources to pursue goals at work and in personal lives.