Pharmacist – Director, Quality Management, Compliance, GxP (m/w/d)

at BioNTech SE
Location Cambridge, Massachusetts
Date Posted August 4, 2022
Category Engineering
Job Type Not Specified

Description

Become a member of the BioNTech Family!
As a part of our team of more than 2.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Director Vendor Compliance Management The Director Vendor Compliance Management ensures that a proactive, risk-based Quality Strategy is established and implemented for clinical development vendor management activities and ensures all aspects of the Vendor Quality Assurance function are on an on-going basis in line with the Quality Management System (QMS).

Your main responsibilities are:

Set up and manage a strategic and pro-active risked based quality oversight on the entire vendor management process (including selection, qualification, and oversight of outsourced activities) in order to ensure continuous inspection readiness and compliance with Regulatory Authorities requirements, Good Clinical Practices and other applicable GxP guidelines, internal standards and adherence to patients' safety, rights and wellbeing.
Qualify vendors and ensure ongoing qualified status. Ensure an adequate QMS is in place at vendors, including Risk management and CAPA processes and ensure that applicable Vendor risks CAPAs are reviewed and approved by BioNTech.
Ensure vendor s oversight via establishment of quality agreements and identification and collection of key quality metrics; perform trending of quality issues at vendors.
Ensure oversight meetings with the Vendor QA team and assign QA experts to other cross-functional meetings and forums.
Attend the key governance Vendor related Leadership meetings and ensure that Quality discussions are part of the key agenda topics on a monthly and quarterly basis to support the QRB meetings.

At least 6 years of experience in a GCP Environment in the Pharmaceutical or CRO Industry.
In depth expertise in worldwide regulations (including FDA, EMA) related to clinical development and post approval.
An understanding of vendor oversight and qualification strategies for regulated Vendors.
Multiple years of experience in Quality functions such as vendor management / auditing / compliance.
Typically requires an academic degree in Life Science (advanced degree preferred).
Experience managing global communities.

Company Pension Scheme
Childcare
Jobticket
Company Bike
Leave Account
Fitness Courses
Mobile Office
Special Vacation

... and much more.

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