Data Integrity Implementation Specialist - Quality

New Haven, Connecticut

Posted: 08/18/19 Category: Professional Job Number: 8050

Position: Data Integrity Implementation Specialist  – Quality
Job Location: New Haven, CT
Type: Contract
Duration: 11  Months
Interview: Phone and In Person

Job Description
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 %)

James Henry
Technical Recruiter

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