Head of Quality Operations and Compliance*
- Gaithersburg, Maryland
- Work experience
- Project Management, Product Management
- Research, development, teaching
Head of Quality Operations and Compliance*
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.
Position is based in our Gaithersburg Site
The Head of Quality Operations and Compliance is responsible for leading and strategically directing the Quality organization and is accountable for the continuous development, execution and administration of a Quality System meeting all compliance requirements with respect to Good Manufacturing Practices (GMP), ICH and EMA regulations for the Gaithersburg Cell Therapy manufacturing site.
The individual will develop, maintain, and continually improve Quality Operations, the Quality Management System, the Quality Assurance program, the Quality Control program, and the Training Program, as well as provide overall Quality and Compliance oversight for the manufacturing and supply chain process.
Here, you’ll achieve greatness.
- Provide Quality Compliance leadership and oversight of Gaithersburg cell therapy manufacturing facility working closely with site leadership, manufacturing, and process development.
- Manage Quality Assurance, Quality Control, and Quality Engineering functions.
- Recommend solutions to complex quality issues and work closely with site and senior management to resolve significant compliance trends and issues.
- Develop and implement processes, procedures, and systems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards.
- Manage audit program against GMP standards, FDA/EMA/ICH requirements, and other regulatory standards and ensure timely resolution of any identified issues.
- Establish and maintain appropriate GMP compliance for product manufacture, testing, and stability; ensure appropriate review and assessment of production records, in-process and release testing methods, specifications, validations, reference materials and test results.
- Manage Quality relationships with GMP service providers
- Ensure Quality Agreements are executed as needed, provide quality input to project plans, master service agreements and statements of work.
- Review technical and study reports, CMC sections of regulatory submissions for compliance with established standards, and regulations.
- Provide Quality input to research on the development of new candidate products
What you have to offer.
- Minimum requirements; Bachelor’s degree, Master’s degree or PhD in science, pharmaceutical sciences or related field
- Minimum 15 years of experience in Quality with at least 10 years of experience in GMP pharmaceutical development, manufacturing, and testing
- Proven track record of critical thinking, agility. This includes the ability to manage priorities, track progress of key projects, and provide updates to leadership as required.
- Thorough knowledge of Phase 1 through Phase 3 product development. Technical knowledge of analytical method qualification, process validation and establishing product specifications
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!