Operational Excellence & IT Compliance Lead
$145,500–$242,500 year
HybridSomerville, New Jersey, United States
Job Summary
Lead site Operational Excellence strategy and IT Compliance governance for GxP computerized systems, establishing continuous improvement roadmaps and monitoring metrics to drive reliability and business value. Provide oversight for the system lifecycle, including validation, change control, CAPA management, and risk assessments, while ensuring adherence to 21 CFR Part 11, FDA, EMA, and GAMP 5 standards. Coach teams in problem-solving, standard work, and Lean methodologies, and serve as the primary escalation point for audit readiness, deviation investigations, and regulatory inspections. Collaborate with site leadership, Quality, and global IT teams to influence compliance frameworks and remove operational barriers. May require up to 10% travel, on-call availability, and shift work.
Required Qualifications
- 8+ years of IT or equivalent relevant experience
- Minimum of 2+ years in the Life Sciences industry
- Must maintain excellent working knowledge of pharmaceutical regulations (e.g. cGMP's, 21 CFR Part 11, Computers Systems FDA) and other applicable regulations (e.g. Privacy, OSHA, etc.) related to laboratory and/or manufacturing environment and system applications
- Ability to work on multiple concurrent project initiatives
- Experience with Lean tools and principals including Six Sigma methodologies
- Basic understanding of General IT concepts, databases (Oracle, SQL, etc.), operating systems (Windows, etc.), system applications, and network switches
- BS/BA in Computer Science or related field required (or equivalent work experience)
- Travel 10% possible
- May be required to be on call
Desired Qualifications
- MS/MBA desirable
- Previous experience in a regulated environment preferred
- Effective problem-solving and analytical skills to resolve operational problems
- Excellent written and verbal communication skills with the ability to develop and present both business and technical presentations
- Ability to build relationships across dimensions of difference, ask questions and invite others to contribute
- Demonstrated business acumen
- Speak up with ideas, concerns and to ensure safety of others
- Demonstrated learning agility, and ability to think creatively, try new ideas and apply learnings
- Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues
- Strong collaboration with colleagues at all levels
- Demonstrate courage and integrity
- Demonstrated success in influencing without authority
- Strong customer service and teamwork oriented
- Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships
- Highly flexible, adapting to changes in priorities, requirements and processes is required
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