Associate Director, Quality Auditing*
- Cambridge, Massachusetts
- Work experience
- Quality Management, Quality Assurance
Associate Director, Quality Auditing*
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.
Here, you’ll achieve greatness.
- Coordinate and complete all aspects of internal and external audit lifecycle: schedule, plan, issue agendas, perform audits, issue reports, evaluate responses and closure of audits.
- Implement, manage Internal Audit Program for Cambridge facility.
- Perform Internal Audits.
- Draft and manage Quality Agreements.
- Participate in the establishment of new vendors (e.g. questionnaires, risk assessments, part setup).
- Manage the system of material supplier corrective action requests/investigations and supplier-initiated changes in timely manner.
- Establish excellent working relationships and communicate with compliance/quality groups, vendors, business partners and other functions.
- Monitor external and internal trends to ensure that audits are focused on emerging areas of regulators risk are incorporated in the audit plan.
- Identify compliance risks and escalate issues to appropriate levels of management.
- Generate and revise standard operating procedures and associated documents as needed.
- Maintain the Approved Vendor List (AVL) and documented evidence of evaluation records.
- Support global alignment on audit and vendor qualification program.
- Collaborate globally with GxP supplier groups to standardize practices.
- Track and communicate auditing and vendor management-specific metrics to management, including but not limited to Quality Management Review.
- Gather metric information for use in continuous improvement of areas of responsibility and report to management, as needed.
What you have to offer.
- Bachelor of Science degree with a minimum of 8 years in Quality Assurance in an FDA - regulated environment and familiar with Health Authority regulations and guidance. Minimum of 5 years’ experience as lead auditor.
- Demonstrated a developed knowledge of compliance requirements, and an understanding of current global and regional trends in compliance.
- Demonstrated ability to incorporate risk management fundamentals in the establishment and adherence of audits conducted.
- Excellent oral, written communication, organizational and interpersonal skills.
- Self-motivated, detail-oriented and comfortable in a fast-paced company environment with minimal direction and able to adjust workload and multi-task productively based upon changing priorities.
- Remote-based; travel may be required up to 40%.
- Experience with virtual and onsite audits. ASQ-CQA certification preferred.
- Knowledge of domestic and internal regulations, including 21 CFR, EudraLex Volume 4 and applicable annexes, USP/EP compendia, ICH and ISO standards and principles.
- Knowledge of clinical operations, manufacturing and testing for Cell or Gene Therapy preferred. Significant experience with e-systems/tools (e.g. Visio, ERP, eQMS, Sharepoint, Teams and Excel, Microsoft Project).
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 firstname.lastname@example.org.
*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!