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Associate Director QA IT Job

Date: Oct 25, 2017

Location: Singapore, SG

Company: MSD

Requisition ID: QUA006433

Associate Director IT QA Asia Pac will be responsible for maintaining, updating, enhancing quality SDLC processes for computerized systems supporting MMD local site systems across AP. You will be the single point of contact to ensure that all MMD Site 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 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

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

  • Min 7 years of experience in regulated pharmaceutical manufacturing with 5 plus 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

  • Multi-lingual capabilities preferred (English/Chinese/Japanese)

  • 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


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


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