Abbott Manager - Clinical Development Quality Systems in Basel, Switzerland
Abbott Established Pharma Division (EPD) is looking for a
Manager Clinical Development Quality Systems
(Clinical Operations, Process and Training)
This position can be based in Basel/Switzerland or Weesp/Netherlands
As Manager Clinical Development Quality Systes for Clinical Operations, Process and Training you will supports the efficient and compliant execution of Clinical Development and Medical activities to internal and external standards by taking responsibility for the maintenance and training of Global Clinical Development & Medical Affairs (CD&MA) Quality System documents.
Core Job Responsibilities:
Develops, and maintains EPD CD&MA quality system documents, adopting Abbott corporate and external standards (ICH/GCP & relevant regulatory requirements)
Serves as subject matter expert and point of contact for CD&MA personnel and cross functional stakeholders for process-related questions
Drives the continuous improvement of global CD&MA policies and procedures; harmonizes activities, promotes best practices
Develops and executes CD&MA compliance strategy. Implement and track compliance metrics and KPI’s. Identify and remediate area’s of non compliance in close collaboration with compliance functions (QA, OEC)
Leads CD&MA audits and inspection activity.
Ensures inspection readiness of CD&MA Global function and promotes inspection readiness in regional/affiliate CD&MA teams.
Assures CD&MA personal have appropriate training plans assigned; promotes and enhances training compliance and manages non-compliance
Identify, on an ongoing basis, operational training needs and coordinate training delivery, where appropriate
Supports in the training and on-boarding of newly hired CD&MA staff
Supervise the Therapeutic Area Review Committee process and assures appropriate process administration
Assures implementation of CD&MA systems and tools in close collaboration with systems owners. Develops strategy to assure data quality.
Collects and processes functional metrics, prepares reports to support Clinical Operations Management decision-making
Takes ownership of continuous learning to stay aware of evolving Abbott policies, regulations and industry practices affecting our procedural standards and quality system documents
- Minimum Bachelor/Master of Science in a field related to life sciences or equivalent by experience
Minimum Experience/Training Required:
At least 10 year experience in Clinical / Medical Affairs Operations
At least 3 years managerial experience in Quality System Management (Development & maintenance quality systems documents and training delivery)
Experience with working in a Global fast paced environnement
People / Line Management experience
Proven Project Management skills
Expert in MS Office applications especially Excel and PowerPoint
Language requirement: Fluency in English, additional languages are a plus
Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today with the location you prefer. We look forward to receiving your application as pdf
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com