Data Integrity Lead Job

Date: Jul 6, 2019

Location: Dublin, IE

Apply now »
Apply now

Apply for Job

Requisition ID: QUA009039

Data Integrity Lead 

& SPECIFIC OBJECTIVES

The Data Integrity Lead will be responsible for implementing the site Data Integrity Strategy ensuring objectives are effectively achieved, consistent with MSD's requirements to ensure compliance, safety and reliable supply to our customers.  
 
POSITION RESPONSIBILITIES

  • Lead Data Integrity (DI) activities at Biotech Dublin for all systems – Laboratory, Manufacturing and IT
  • Lead business process design efforts relating to DI solutions
  • Chair the site DI council
  • Coach and mentor a matrix team to deliver on the DI strategy
  • Development and leadership of a governance structure to allow for sponsorship and partnership of the site Snr leadership team and global centres of excellence
  • Ensure that all project milestones for DI are met
  • Support DI training on site as required to up skill and increase DI awareness
  • Complete periodic DI audits across the site
  • Manage change execution for DI related changes
  • Maintain the site DI communications board
  • Be the primary liaison between site and the global DI COE
  • Participate and attend Global DI CoE workshops as applicable
  • Participate in additional training on data integrity and industry requirements as required
  • Represent Biotech Dublin at the DI Communities of Practice to support sustained alignment across our manufacturing division network
  • Lead communications to the sustaining sponsors, senior leadership and department leadership teams as appropriate.
REPORTING STRUCTURE
The DI site Lead will report to the Associate Director, Quality Assurance 
Qualifications

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

 
General

  • Demonstrated problem solving skills
  • Continuous improvement skills
  • Planning and Scheduling
  • Excellent project management skills
  • Expert knowledge of GMP/Data Integrity and experience with regulatory inspections is required
  • Assertive and a very strong communicator who can develop contacts internally and external to the network
Technical  

  • A minimum of 5 years’ experience in a pharmaceutical environment.
  • A minimum of 2 years’ Quality experience
  • Knowledge of relevant GMP and DI standards
  • Deep understanding of current regulatory requirements and expectations
  • Validation of IT systems
  • Auditing of IT systems
  • Strong scientific understanding
  • Knowledge of relevant regulatory requirements for DI, including GMPs
  • Skilled Change Manager
  • Planning and Scheduling
  • Strong DI/IT knowledge/abilities
People

  • Ability to interact with multiple stakeholders across numerous departments
  • Ability to work independently and as part of a team. 
  • Excellent communication skills and the ability to work in a cross functional collaborative environment.  
Education

  • BSc. (or equivalent experience base) in Science/Engineering or a related discipline.

MSD is not accepting unsolicited assistance from search firms / recruitment agencies 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: Quality Operations
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Database, Biotech, Engineer, Law, Pharmaceutical, Technology, Science, Engineering, Legal

Apply now »
Apply now

Apply for Job