Senior Quality Expert / Compliance Lead (RE2762)

Brine SA is looking for a Senior Quality Expert for our Client in Basel.

Responsibilities:

  1. Implementation Lead of Third Party Engagement and Oversight Program, with a special focus on Governance, that includes GOP & SQA rollout, in line with new Medical Affairs Third Party Operating model.
  2. Implementation Lead accountable to rollout the Medical Third Party Engagement Guiding tool at G/R/L level, and also acting as the SPOC for all related activities.
  3. Accountable to design and implement the Governance & Oversight framework of the Medical Affairs Third Parties, in close collaboration with the “activity owners” and respective functions (eg ESPQA)
  4. OMA Third Party (TP) Implementation & Operations Lead will provide overall leadership, guidance and support to regional and local resources responsible for Medical Affairs Third Party qualification and oversight, in line with relevant GOPs
  5. Review and update Third Party / ESP (Vendor) partnering strategy jointly with procurement and the regional and local medical teams
  6. Single Point of Contact (SPOC) to Medical Affairs on Third Party and ESP (Vendor) engagements, governance and oversight
  7. Provide ESP SME supporting the goals of OMA, in line with the transformation Plan of Governance and Compliance Function
  8. Provide subject matter expertise and act as OMA representative to EDO for ESP qualification/re-qualification and oversight
  9. Support activities for HA inspections/Audit readiness, establish and Develop Collaborative Partnerships
  10. Represent OMA in ESP Governance Boards when required and liaise with Procurement and relevant functions
  11. Support business partners in Third Party / ESP in issue remediation.

Ideal Background:

Education (minimum/desirable): Bachelor’s degree required; Relevant advanced degree
(MBA, PharmD, MD or PhD preferred)

Languages: English: fluent written and spoken

Experience/Professional requirement:

  • 10+ years relevant industry experience, including expertise in clinical operations leadership of multidisciplinary teams, experience management outsourced trial activities at an operational and strategic level
  • Proven people leadership in ESP management
  • Experience with clinical processes and associated ESP services, with excellent understanding trial management, trial monitoring and overall integration of clinical data system and processes
  • Strong technical and problem solving skills Excellent understanding of clinical trial methodology, GCP and medical terminology
  • Excellent understanding of clinical dev., quality & regulatory standards and policies relevant to defined Services
  • Provide thought-leading insights to the competitive environment and internal partner interfaces
  • Outstanding skills to facilitate/optimize contribution of team members as individuals and members of cohesive team
  • Excellent interpersonal and communication skills, able to naturally bridge scientific and business participants; Track record in enabling effective international collaboration

Work location:       Basel

Duration:                 1/4/2021 to 31/03/2021

Workload:               100%            

Salary:                     to be discussed

To learn more about this opportunity please send your CV ASAP in Word format to Brine SA.   hrs@brine.ch