Director IT QA – Laboratory Systems Validation & Compliance Job

Employer
Merck
Location
West Point, PA, US
Posted
October 12 2017
Discipline
Other
Organization Type
Pharma
Requisition ID: QUA006318

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 QA
Director for Laboratory Systems will lead the team responsible for
maintaining, updating, enhancing quality SDLC processes for computerized
systems supporting MMD Lab operations. You will be the single point of
contact to ensure that all Laboratory systems supporting GMP activities are in
compliance with regulatory requirements from implementation through
operations, support and retirement. As a leader of the team, your
responsibilities will include (but not limited to):


·     Collaboration
with MMD business functions & IT to asses/select/implement innovative technology solutions and upgrade existing
solutions driving efficiency & compliance for GMP Lab systems


·     Coordination
& communication of system health, compliance and other metrics to key
stakeholders


·     Facilitation Lab
process improvements and validation activities including preparation, review,
and approval of documentation


·     Supporting audit
activities for all Lab IT applications & infrastructure (both at site and
above site)


·     Leading
pre-inspection IT readiness and provide technical support during inspection


·     Driving
resolution to regulatory non-conformance of GMP Lab systems (both internal &
external)


·     Interfacing
with MMD IT and other internal & external entities to align GMP Lab technology
capabilities/solutions with MMD quality objectives


·     Maintain/update/enhance
Quality SDLC processes & IT controls or all GMP Lab systems


·     Supporting
QSIP (and other ongoing MMD initiatives) work-streams


·     People
management






Qualifications

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

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 

 

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

  

Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

 

Visa sponsorship is not available for this position.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            EEOC Poster

            EEOC GINA Supplement 



Job: Qual Assurance & Ops Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck