Director of Quality Systems and Compliance *

  • Cambridge, Massachusetts
  • Work experience
  • Quality Management, Quality Assurance
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Director of Quality Systems and Compliance *

Become Part of the BioNTech Family.

BioNTech US serves as BioNTech’s North American headquarters and is an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies. BioNTech US is a fully integrated subsidiary with a strong foundation in Europe and a focus on the development of novel neoantigen-targeted T cell therapies, complementing BioNTech’s highly innovative scientific approach and diversified pipeline of transformative cancer medicines. As a key research and clinical development hub, BioNTech US will enable BioNTech’s growing presence in the US.

The Director of Quality Systems and Compliance will lead the company’s quality and compliance programs to ensure a pragmatic and risk-based approach to quality risk management, controls and governance while ensuring applicable cGMP, GLP, and GCP regulations are met. The individual will provide operational and strategic input to cross-functional teams and ensure effective collaboration communication with colleagues to enable global development of BioNTech products.

 

Here, you’ll achieve greatness.

The areas of responsibilities will include:
 
  • Build-out, management, and continuous improvement of the quality systems to support program development and registration
  • Process alignment with corporate policies and procedures
  • Maintaining and managing supplier qualification program including support for audits, site inspection readiness and management of quality agreements.
  • Manages the document control program, including periodic review and record retention.
  • Implementation and facilitation of GxP training programs
  • Manages the computer system assurance program
  • Provide analysis and counsel on domestic and international compliance matters and support and develop Company responses to compliance concerns.
  • Establish risk management systems
  • Identify and communicate risks and coordinate development of mitigation plans
  • Build a strong Quality Management organization through hiring and talent development.
  • Trend performance of the Quality Management System and provide metrics to leadership for review.

What you have to offer.

  • Minimum requirements; Bachelor’s degree, 10 plus years quality experience and 3 years in a leadership role.
  • Previous experience in an FDA (and/or other Health Authority) regulated environment and familiar with Health Authority regulations and guidance.
  • Previous experience developing and maintaining Quality Systems for clinical phase company
  • Ability to work effectively/congenially both independently and with a multi-disciplinary team
Preferred requirements; Life Sciences experience. Experience with Computer System Validation

Benefits for you.

BioNTech US is committed to the well being of our team members and offers a variety of benefits supporting our diverse employee base. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:
  • Medical, Dental and Vision Insurance
  • Life, AD&D, STD and LTD Insurance
  • HSA & 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
Plus more benefits that will be shared upon hire!

Have we kindled your pioneering spirit?

Then apply now for our location Cambridge (Boston) and simply send us your application documents using our online form.

For those who require assistance due to disability, or have questions prior to applying, please email careers@join-us.biontech.de.

*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!


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