Quality Assurance Operations Manager *
- Cambridge, Massachusetts
- Work experience
- Quality Management, Quality Assurance
Quality Assurance Operations Manager*
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 Quality Assurance Operations Manager will partner internally with Technical Operations, Quality Control, Process and Product Development, Regulatory, CMC Leadership and Supply Chain functions to drive external technical transfer and production activities. The individual will provide quality leadership and oversight of immunogen and cell therapy contract manufacturing organizations using phase appropriate quality systems to ensure the availability of product for BioNTech’s clinical trials and foster strong relationships with external partners to build a quality focused, efficient and collaborative culture to meet department and company goals.
Here, you’ll achieve greatness.
- Ensuring products for human use are manufactured in compliance with the applicable requirements, regulations and guidance and meet appropriate quality specifications and standards
- Responsible for the disposition of critical raw materials and cell therapy drug products produced in contract manufacturing operations (CMO).
- Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition
- Provide QA support of technical transfers including Analytical method transfer, stability program, quality events, risk assessments, change controls, deviations, investigations (OOS, OOT), and CAPAs
- Supports the development and implementation of GMP Quality Systems such as disposition, vendor management, deviations, CAPA, and change controls
- Work collaboratively with internal cross-functional team and CMO to resolve issues during production and testing
What you have to offer.
- Minimum requirements; BS in Chemistry, Pharmacy, Biology, or a related life science with 6 plus years of experience within the GMP quality function of the pharmaceutical/biotech industry
- Knowledge of cGMP regulations for Phase 1 – 3 clinical trials, ICH and global regulatory guidance
- Direct experience working with CMOs to meet product disposition timelines.
- A strategic thinker that can break down barriers, drive great decisions, and make an impact in a rapidly growing small company
- Some auditing experience is a preferred
- Experience with a cell therapy product is preferred
- Must be willing to travel domestically and internationally up to 20%
Preferred requirements; Auditing experience Experience with auditing and work with a cell therapy product.
Benefits for you.
- 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
Have we kindled your pioneering spirit?
For those who require assistance due to disability, or have questions prior to applying, please email email@example.com.
*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!