Associate Director, Computer Systems Validation

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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.

Shift Available:

• Monday - Friday, Hybrid Day Shift, 8 a.m. - 5 p.m.

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 multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.

• 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. Innate ability to learn new software, such as corporate intranet and enterprise business.

• Ability to create and analyze meaningful metrics.

Knowledge & Skills:

• Thorough knowledge of cGMP in the pharmaceutical industry.

• Advanced computer skills and demonstrated knowledge of validating computer systems used in the pharmaceutical industry

• Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.

• Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.