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Associate Director – IT QA EMEA Job

Date: Nov 21, 2017

Location: Haarlem, NH, NL

Company: MSD

Requisition ID: QUA006458

The position

The Associate Director IT QA EEMEA will be responsible for maintaining, updating, enhancing quality SDLC processes for computerized systems supporting MMD (Manufacturing Division) local site systems across Europe. You will be the single point of contact to ensure that all MMD Site systems supporting GMP (Good Manufacturing Practices) 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 systems at various MMD Sites;

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

  • Promoting a culture of continuous improvement and facilitating manufacturing process improvements and validation activities including preparation, review, and approval of relevant documentation;

  • Supporting audit activities for all shop-floor applications & infrastructure (at local sites);

  • Leading pre-inspection IT readiness and provide technical support during inspection (in conjunction with other teams);

  • Driving resolution to regulatory non-conformance of GMP shop-floor systems (both internal & sometimes external manufacturers);

  • Interfacing with MMD IT and other internal & external entities to align GMP shop-floor technology capabilities/solutions with MMD quality objectives;

  • Maintain/update/enhance Quality SDLC processes & IT controls for all GMP shop-floor systems;

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

  • People management and leading matrix teams.

Qualifications

Desired skills & experience

Education Minimum Requirement:



  • Bachelor's degree in Science, Information Technology 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 shop-floor systems supporting pharmaceutical manufacturing operations;

  • Multilingual (besides English);

  • Min 7 years of experience in regulated pharmaceutical manufacturing with 3-5 years of experience in delivering validated IT solutions or an application support role;

  • 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.

About MSD
MSD 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 MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.



A good place to work 


Your role at MSD 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 MSD, we’re inventing for life. 


Application
If you are interested in this challenging role, you are requested to apply online by uploading your resume and application letter in English.


 


 


Search Firm Representatives Please Read Carefully:
MSD 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 MSD 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 MSD. No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.



Job: Qual Assurance & Ops Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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