2 Director, Vendor Compliance Management Jobs in Cambridge, MA
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Director, Vendor Compliance Management
$147k-190k (estimate)
Full Time | Scientific Services
3 Days Ago
BioNTech SE is Hiring a Director, Vendor Compliance Management Near Cambridge, MA
Join our team of pioneers! As a part of our team of more than 5.000 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 of Vendor Compliance Management is responsible for the development/maintenance/execution of a risk based vendor compliance strategy. The Director of Vendor Compliance Management has oversight of the qualification process, and ensures that controls such as quality assurance agreements are in place. The Director of Vendor Compliance Management has manages a team of global full time staff.
Your Main Responsibilities Are
How to apply: Apply now and simply send us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details by using our online form.
Please note:
www.biontech.com
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 of Vendor Compliance Management is responsible for the development/maintenance/execution of a risk based vendor compliance strategy. The Director of Vendor Compliance Management has oversight of the qualification process, and ensures that controls such as quality assurance agreements are in place. The Director of Vendor Compliance Management has manages a team of global full time staff.
Your Main Responsibilities Are
- Lead team of QA personnel located in different geographical locations.
- Maintain strong relationships with internal and external stakeholders.
- Ensure adherence to departmental procedures and ensure documentation produced per execution of SOPs is inspection ready.
- Establish and maintain relevant KPIs.
- Support inspection activities upon request.
- Design and/or manage a strategy and proactive risk based quality oversight for vendors to ensure continuous inspection readiness and compliance with regulatory requirements.
- Manage vendor qualification process and ensure maintenance of the vendor qualification database.
- Ensure vendor oversight once qualified via execution of quality assurance agreements, QA-QA calls, etc.
- Academic degree in Life Science preferred
- Masters degree desired, although additional work experience would be considered instead
- Significant experience in quality assurance within a regulated clinical environment in the Pharmaceutical industry with a good understanding of clinical development activities typically gained through a minimum of 10 years.
- Relevant experience in building and maintaining business partner relations that include partnering with and providing service to business functions, typically gained through a minimum of 8 years
- Robust experience in interpreting GCP guidelines for the pharmaceutical industry as they apply to vendors
- Strong and proven team leadership experience, gained through at least 8 years of experience
- Deep knowledge and experience in drug development, development of medical devices, clinical development, research operations, GCP, GLP, GPVP, GCP for Labs, general understanding of GMP
- Knowledge of and ability to apply process development expertise, industry standard problem-solving approaches, in alignment with Lean and Lean Six Sigma principles
- Knowledge and experience in Inspection Readiness
- Ability to travel (at least 15%)
- Experience with due diligence, vendor qualification and vendor compliance oversight.
- Experience in collaborating with key internal stakeholders and service providers (e.g. CROs) to ensure adequate quality oversight of vendors.
- Robust experience in worldwide regulations and guidelines (including ICH, FDA, EMA) related to clinical trial development and post-approval medicinal products, typically gained through a minimum of 10 years.
- Proven leadership with teams, mentoring, and guiding team members development
- Strong experience in developing and maintaining a proactive, risk-based Vendor Quality Strategy
- Computer literacy, including MS Office suite (Excel, PowerPoint, Office, etc.)
- Experience in a quality management system
- Demonstrated functional knowledge
- Strategic project development and project management
- Resource and budget planning
How to apply: Apply now and simply send us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details by using our online form.
Please note:
- Only applications sent via our online form shall be considered.
- Only Candidates with the right qualifications and relevant experience shall be shortlisted and
- Incomplete applications shall be rejected.
- Please note that BioNTech will run a background check during the hiring process
- BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
www.biontech.com
Job Summary
JOB TYPE
Full Time
INDUSTRY
Scientific Services
SALARY
$147k-190k (estimate)
POST DATE
07/04/2024
EXPIRATION DATE
07/31/2024
WEBSITE
biontech.de
HEADQUARTERS
MAINZ, RHEINLAND-PFALZ
SIZE
1,000 - 3,000
FOUNDED
2008
CEO
UGUR SAHIN
REVENUE
$500M - $1B
INDUSTRY
Scientific Services
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