Job Detail

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Fisher Clinical Services GmbH is part of Thermo Fisher Scientific Corporation, a world-class company serving the scientific community and healthcare industry. We are leaders in providing clinical supply chain management services and clinical supplies distributed to patients worldwide. For more information about our site in Allschwil please visit: www.fisherclinicalservices.com

Team Leader GMP Documentation

The Team Leader has leadership responsibilities (7 direct reports) and is accountable for the work of the documentation specialists team within the client services project management packaging department. The Team Leader organizes the team to write all kind of GMP relevant documents for the Client Services Department. These are beside others the batchrecords and Change Orders for Manufacturing, Primary- and Secondary Packaging and the links reports with the variable data information for the labelling printing activities.

Team Lead Documentation Specialists will support the team with daily activities while establishing and implementing appropriate processes to support productivity enhancements.
The role requires an in-depth understanding of clinical trial supplies and the services that Fisher Clinical Services GmbH (FCS) can provide according to FCS quality standards and timelines.

Responsibilities:

• Develops, mentors and performs annual reviews for the documentation specialist team. Develops individual development plans but also development performance improvement plans when necessary.


• Establishes Goals for direct reports in accordance with company initiatives and vision.


• Identifies, develops and implements process improvements to support overall efficiency and productivity of the documentation specialist team


• Collecting, preparing and evaluating KPIs, measuring/pacing team performance


• Handles all personnel issues, timecard maintenance and job descriptions as required for all direct reports.


• Participates in internal kickoff meetings or any other relevant pre- and post-operations meeting with other internal stakeholders.


• Supports customer calls, customer visits and audits as needed to represent team functions.


• Ensures close collaboration with Team Leaders of project managers but also other stakeholders as QA and operations for daily interactions but also process improvement activities


• Provides training, including system trainings and SOP trainings on regular basis


• Applies Good Manufacturing Principles in all areas of responsibility.


• Demonstrates and promotes the company vision.

Qualifications:

• Requires accredited college, university or recognized professional degree, preferably in a health-related field.


• Several years of experience in the pharmaceutical industry in quality control/ quality assurance, project management or operations


• Requires GxP training and experience


• Understanding of clinical trials is a plus


• Experienced working with direct management of teams


• Preferably experienced with internal/ external customers in a dynamic environment


• Command of English and German at professional level

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today jobs.thermofisher.com