Director* Clinical QA Compliance

  • Cambridge, Massachusetts
  • Work experience
  • Quality Management, Quality Assurance
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Company Profile

BioNTech is a Germany-based biotechnology company with U.S. offices in Cambridge, MA and Gaithersburg, MD, that focuses on developing cancer therapeutics, including individualized immunotherapy, as well as vaccines for infectious diseases, including COVID-19. The company's oncology pipeline contains several classes of drugs, including mRNA-based drugs to encode antigens, neoantigens, cytokines, and antibodies; cell therapies; bispecific antibodies; and small-molecule immunomodulators. BioNTech is partnered with several large pharmaceutical companies, including Roche, Eli Lilly, Pfizer, Sanofi, and Genmab. Comirnaty (COVID-19 vaccine) is its first commercialized product.
 

Director* Clinical QA Compliance

The Director* Clinical QA Compliance ensures that a proactive, risk-based Quality Strategy is established and implemented for the clinical development activities within a portfolio. This role leads a team of QA personnel located in different geographical locations and ensure the values of transparency, speak up, and pro activity are embedded as part of the vision of the team.

Your main responsibilities are:
  • Proactively provide strong QA leadership to the Development organization by ensuring considerable organization awareness (e.g., interrelationship of departments and business priorities)
  • Ensure the implementation of the Clinical Development Quality Plan within the development portfolio
  • Provide robust quality oversight in the following areas:
  • Proactively support / collaborate with key stakeholders to ensure that risks are detected and remediated
  • Provide guidance to day-to-day questions arising from Clinical trials deliverables
  • Collaborate with Clinical Development Operations to drive initiatives relevant to outsourced activities
  • Support inspections preparation and facilitation in collaboration with other QA groups
  • Support audits and inspections follow-up activities including CAPA preparation
  • Manages a pro-active risked based quality oversight on the clinical trial process in order to ensure continuous inspection readiness and compliance with Regulatory Authorities requirements, Good Clinical Practices and other applicable GXPs, internal standards and adherence to patients' safety, rights and wellbeing
  • Ensures QA expertise and proactive guidance are provided to clinical trial teams, to ensure that high priority programs and quality initiatives meet defined expectations

What you have to offer.

  • At least 8 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
  • Multiple years of experience in Quality functions such as auditing / compliance
  • Typically requires an academic degree in Life Science (advanced degree preferred)
  • Experience managing global communities

Benefits for you.

  • Medical, Dental and Vision Insurance
  • Life, AD&D, STD and LTD Insurance
  • HRA & FSA Spending Accounts
  • Health & Wellness, including free onsite gym access
  • Adoption & Surrogacy Assistance
  • Vacation and Unlimited Sick Time
  • Holidays and Floating Holidays, including discretionary winter shutdown
  • 401(K) Plan with Significant Company Match
  • Tuition Reimbursement and Professional Development
  • Commuting Assistance and free onsite parking
  • Discounted Home and Auto Insurance
  • Pet Insurance
  • And more!

Have we kindled your pioneering spirit?

Then apply now for our location Mainz and simply send us your application documents using our online form.

If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm CET).

Job-ID 6365 #LI-DCA (please indicate for inquiries)

We look forward to your application!

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

https://biontech.de