Senior Director* Clinical QA Compliance

  • Cambridge, Massachusetts
  • Work experience
  • Quality Management, Quality Assurance
scheme imagescheme imagescheme image

Company Summary

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.

Senior Director* Clinical QA Compliance

The Senior Director* Clinical QA Compliance ensures that a proactive, risk-based Quality Strategy is established and implemented for early & late phases and commercial clinical development activities. This role also ensures that the Quality Management System (QMS) is robust, compliant with all applicable regulatory requirements and with internal standards and drives continuous improvement of the QMS.

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 implementation of the quality strategy within all levels of clinical development organization (Portfolios, platforms and studies) and the timeliness implementation of the Clinical Development Quality Plan
  • Identify and lead continuous improvement initiatives and make sure that areas identified as weaknesses are properly being addressed and executed for sustainability
  • Attend the key governance Development Leadership meetings and secure that Quality discussions are part of the key agenda topics on a monthly and quarterly basis to support the QRB meetings
  • Ensure Clinical QA experts are assigned to cross departmental and GxP projects (e.g., Clinical Safety, Clinical Trial Supplies, Pharmacology, Pharmacokinetics & biomarkers). Lead continuous improvement initiatives (including workstreams) and ensure that areas identified as weaknesses are properly addressed and executed for sustainability

What you have to offer.

  • At least 15 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 6363 #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