Brine SA is looking for a Senior Quality Expert for our Client in Basel.
- 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.
- 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.
- 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)
- 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
- Review and update Third Party / ESP (Vendor) partnering strategy jointly with procurement and the regional and local medical teams
- Single Point of Contact (SPOC) to Medical Affairs on Third Party and ESP (Vendor) engagements, governance and oversight
- Provide ESP SME supporting the goals of OMA, in line with the transformation Plan of Governance and Compliance Function
- Provide subject matter expertise and act as OMA representative to EDO for ESP qualification/re-qualification and oversight
- Support activities for HA inspections/Audit readiness, establish and Develop Collaborative Partnerships
- Represent OMA in ESP Governance Boards when required and liaise with Procurement and relevant functions
- Support business partners in Third Party / ESP in issue remediation.
Education (minimum/desirable): Bachelor’s degree required; Relevant advanced degree
(MBA, PharmD, MD or PhD preferred)
Languages: English: fluent written and spoken
- 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
Salary: to be discussed
To learn more about this opportunity please send your CV ASAP in Word format to Brine SA. email@example.com