Director IT QA – Laboratory Systems Validation & Compliance
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The IT QADirector for Laboratory Systems will lead the team responsible formaintaining, updating, enhancing quality SDLC processes for computerizedsystems supporting MMD Lab operations. You will be the single point ofcontact to ensure that all Laboratory systems supporting GMP activities are incompliance with regulatory requirements from implementation throughoperations, support and retirement. As a leader of the team, yourresponsibilities will include (but not limited to):
· Collaborationwith MMD business functions & IT to asses/select/implement innovative technology solutions and upgrade existingsolutions driving efficiency & compliance for GMP Lab systems
· Coordination& communication of system health, compliance and other metrics to keystakeholders
· Facilitation Labprocess improvements and validation activities including preparation, review,and approval of documentation
· Supporting auditactivities for all Lab IT applications & infrastructure (both at site andabove site)
· Leadingpre-inspection IT readiness and provide technical support during inspection
· Drivingresolution to regulatory non-conformance of GMP Lab systems (both internal &external)
· Interfacingwith MMD IT and other internal & external entities to align GMP Lab technologycapabilities/solutions with MMD quality objectives
· Maintain/update/enhanceQuality SDLC processes & IT controls or all GMP Lab systems
· SupportingQSIP (and other ongoing MMD initiatives) work-streams
Education Minimum Requirement:
- Bachelor's degree in Science, Information Technology, Bioengineering, Pharmacy or equivalent.
- Advanced degree preferred
- Certification in Six Sigma and/or a certification in project management (PMP)
Required Experience and Skills:
- Hands-on experience and understanding of major Lab Systems (like NuGenesis, Empower, LabWare, Nucleus etc.) supporting pharmaceutical QC/QA/manufacturing operations
- Leading teams performing analytical testing for pharmaceutical products commercialization and executing QA/QC functions supporting pharma manufacturing, product release and stability testing
- Min 10 years of experience (7 years with Advanced Degree) in regulated pharmaceutical manufacturing
- Strong understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, 58 and 820
- Must demonstrate extensive knowledge of the principles, theories and concepts of computerized system validation / compliance
- Familiarity and practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment
Preferred Experience and Skills:
- Good understanding of IT related to computerized systems development, implementation & Operations
- Business engagement skills, with ability to collaborate with both technical and non-technical roles
- Experience in leading conversation during regulatory inspections
- Ability to understand business needs and map to IT technical solutions
- Up to speed on technology with ability to understand new/changes and provide guidance on solutions
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Visa sponsorship is not available for this position.
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Job: Qual Assurance & Ops Generic
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck