Data Integrity Project Manager

Pharmica Consulting - Boston, MA

The position is in the Global Quality Enterprise GxP e-Systems department within the Data Integrity Governance group and is responsible for driving the implementation of an effective GxP Data Integrity Governance Program (the Program) across the end-to-end (R&D, Operations and Supply Chain) product lifecycle to ensure that regulatory and requirements are addressed in a thorough effective, and timely manner.

  • Drive implementation of Data Integrity Governance Program milestones through coordination and execution of cross-functional deliverables.
  • Write and/or edit procedural documentation and training materials to ensure an ongoing state of Data Integrity compliance across the GxP product lifecycle, as well as all sites and internal functions.

Principal Responsibilities

Provide hands-on development, execution and coordination of activities related to Data Integrity Governance Program including development of DI plans, assessment tools, process maps and gaps remediation plans and execution

  • Provide active support during regulatory agency and third party inspections
  • Develop and utilize metrics and KPIs to assure programs’ success
  • Facilitate Data Integrity Community of Practice
  • Provide program and project management of Data Integrity Governance Program
  • Develop and deliver cross-functional DI training and knowledge management
  • Promote cross – functional partnership developing “DI by design” sustainable state


Qualifications

  • Cross-functional experience in three or more areas (i.e. Research, Analytical/QC, QA, Engineering, manufacturing, Regulatory etc.) is desired

  • Experience in Pharmaceutical or BioTech manufacturing or clinical research desired
  • Proven record successfully implementing DI Governance program
  • Ability to collaborate and lead cross-functionally to help drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites and internal functions
  • Subject matter expertise in DI regulatory requirements and risk management
  • Ability to build alignment with business partners
  • Demonstrated strong project management focus as well as focus on tactical execution of strategic decisions while balancing conflicting priorities
  • Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk
  • Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments
  • Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights
  • Good understanding of the drug and device development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing and distribution processes
  • Must understand industry accepted software development and validation life cycle programs
  • Excellent interpersonal skills, including written and verbal communication
  • Strong sense of ethics, diplomacy and discretion
  • Commitment to Quality
  • Strong critical thinking to analyze complex situations and discern critical issues
  • Able to work effectively with multicultural workforce
  • Excellent team player attitude

     

    Education

  • Bachelor’s degree in Scientific, Engineering, or Business discipline required.

  • Lean Six Sigma training desirable
  • PMI knowledge and certification desirable

     

    Competencies

  • Extensive knowledge of the effective Risk Management practices

  • Data Integrity and GAMP 5 expert
  • Detail oriented with a bias for action
  • Demonstrated cross-functional networking skills
  • Strong written and verbal communication skills
  • Demonstrated problem solving capabilities
  • Capable of identifying and mitigating risks
  • Accountable business partner with a focus on collaborating and delivering results.
  • May require international travel (10 %)


Posted On: Wednesday, July 17, 2019



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