Director, GCP Quality Assurance*
- Cambridge, MA
- Senior, very experienced
- Executive Middle Management
- Quality Management, Quality Assurance
Director, GCP Quality Assurance*
Based in Cambridge, MA, 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.
BioNTech US is seeking a highly motivated leader with cGCP experience to join the Quality Assurance team. The Director, GCP Quality Assurance will be responsible for implementation of the GCP quality function at BioNTech US and is accountable for GCP compliance in accordance with ICH, US, and EU regulations. The director will ensure oversight of GCP activities both internally and externally to ensure compliance and preparedness in line with Phase-appropriate activities. The QA leader drives, promotes, and embeds a culture of ethics, integrity and continuous improvement that will focus on delivering efficiencies and business benefits to support the development of BioNTech products and programs. The newly hired director will report to the Sr. Director of US Quality Assurance and work in close collaboration with the Clinical development, Clinical Operations, Supply Operations, and R&D teams.
Here, you’ll achieve greatness.
- Formulating a GCP Compliance strategy and providing Quality guidance for all development programs
- Managing quality reviews of clinical and nonclinical study documents and regulatory submissions
- Participating in CMC and Core Program teams to strategize GCP quality planning and regulatory filings
- Providing quality oversight for all external clinical quality systems, including CROs, investigator sites, independent studies, central labs, non-clinical study laboratories and other key partners supporting BioNTech’s clinical and pharmacovigilance programs
- Performing and organizing quality audits of CROs, clinical, data management/processing, and pharmacovigilance vendors and activities; Utilizing audit results to drive improvement and reduce risk to BioNTech’s clinical trials
- Establishing and implementing clinical quality policies and procedures.
- Managing (author/review/negotiate) Quality Agreements with CROs and clinical vendors.
- Planning and overseeing day-to-day activities of the Quality function including management of consultants/auditors as needed to ensure project and business needs are met
- Providing input and support in partnership with teams across R&D and clinical operations
- Developing and overseeing appropriate Quality metrics
- Reporting on the state of BioNTech’s compliance to senior management and advising them of critical quality and compliance related issues and corrective actions to mitigate quality and compliance risks
- Keeping abreast of industry developments, forthcoming regulations, guidance, best practices etc.
- Assisting in the support the overall Quality Management Systems at BioNTech US
What you have to offer.
- BS in Chemistry, Pharmacy, Biology or a related life science. Master’s degree preferred
- Minimum of 8-15 years of experience within the Clinical quality function of the pharmaceutical/biotech industry
- Extensive knowledge and in-depth experience of implementation of Quality Systems, PV, and cGCP Quality regulations for USA, EU and other global Health authorities; Signficant experience in Pharmacovigilance (GVP) strongly preferred
- Experience in implementation of Clinical Quality systems
- At least 3 years of GLP and GCP auditing experience (e.g. CROs, nonclinical study labs) and ability to deliver timely reports and assessments
- Previous experience preparing for regulatory filings. Experience with marketing authorization applications preferred
- Pro-active in identifying opportunities with a strong solution minded approach and flexibility to emerging challenges
- Strong collaborative, influencing and interpersonal skills with excellent verbal, written and presentation skills with the ability to deal effectively across all levels of management
- Ability to prioritize competing activities and manage resources and budget accordingly
- Ability to maintain and create professional networks with stakeholders internally and externally
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, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.
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