Associate Director – Computer Systems Validation
| Company | Bristol Myers Squibb |
|---|---|
| Location | Summit, NJ, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Expert or higher |
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 with direct interaction including face to face interaction and response to audit questions.
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.
Preferred Qualifications
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No preferred qualifications provided.