Senior Quality Expert/Compliance Lead
Posted on Feb 15, 2021 by RM IT Professional Resources AG
Senior Quality Expert/Compliance Lead (w/m) vacancy for a globally operating Basel based company in the pharmaceutical sector.
- At least a Bachelor's degree or a relevant advanced academic degree such as MBA, PharmD, MD or PhD
- 10+ years relevant industry experience, including expertise in clinical operations leadership of multidisciplinary teams as well as experience management outsourced trial activities at an operational and strategic level
- Expertise with clinical processes and associated ESP services, with excellent understanding trial management, trial monitoring and overall integration of clinical data system and processes
- Excellent understanding of clinical trial methodology, GCP and medical terminology as well as of clinical development, quality and regulatory standards and policies relevant to defined Services
- Proven people leadership in ESP management paired with outstanding skills to optimize contribution of team members as individuals and members of cohesive team
- Excellent interpersonal and communication skills combined with the ability to naturally bridge scientific and business participants
- Languages: English, fluent in written and spoken
- Leading the implementation 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
- Directing the implementation of Medical Third Party Engagement Guiding tool at G/R/L level, and also acting as the SPOC for all related activities
- Designing and implementing the Governance & Oversight framework for the Medical Affairs Third Parties in close collaboration with the "activity owners" and respective functions such as ESPQA
- Providing as OMA Third Party Implementation & Operations Lead guidance and support to regional and local resources responsible for Medical Affairs Third Party qualification and oversight in correspondence with relevant GOPs
- Reviewing and updating Third Party/ESP (Vendor) partnering strategy jointly with procurement and the regional and local medical teams
- Granting ESP SME support in the achievement of the goals of OMA, in line with the transformation Plan of Governance and Compliance Function as well as in activities in HA inspections/Audit readiness
- Contributing in the subject matter expertise and acting as OMA representative to EDO for ESP qualification/re-qualification and oversight
- Representing OMA in ESP Governance Boards when required and liaising with Procurement and relevant functions as well as supporting business partners in Third Party/ESP in issue remediation
Location: Basel, Switzerland
Does this Spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
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