Senior Specialist, Quality Systems*
- Gaithersburg, Maryland
- Work experience
- Quality Management, Quality Assurance
Senior Specialist, Quality Control Analytical*
This position is based in Gaithersburg, MD at our newly formed clinical manufacturing site for BioNTech US. Together with the BioNTech US North American Headquarters in Cambridge, MA, both the Gaithersburg and Cambridge sites are an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies that expects to experience significant growth in the near future. BioNTech US is a subsidiary of BioNTech SE 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.
We are seeking a highly motivated individual to join as a Senior Specialist, Quality Systems. In this role, you will ensure quality product and timely delivery – every patient, every time. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy. This position will provide oversight of BioNTech’s quality systems including deviations/OOSs, CAPAs, Change Controls, Internal Auditing and reporting associated Metrics, reporting into the Sr. Manager of Quality Assurance.
Here, you’ll achieve greatness.
Additional job duties include:
- Implement, manage, audit and maintain BioNTech’s quality systems.
- Ensure quality systems conform to regulations and quality policies.
- Implement Quality Systems governance for Deviations, OOSs, CAPAs, Change Controls and Internal Auditing.
- Implement, manage and perform Internal Audit Program at Gaithersburg facility.
- Support all site audits and regulatory inspections.
- Support New Hire Orientation and Train-the-Trainer training content and delivery.
- Support, develop and deliver technical and/or compliance training to BioNTech’s staff (including quality systems and E-Systems).
- Support and develop quality system site governances. Oversee deviation, CAPA, Change Control and records management program.
- Support tracking and communication of site metrics to management, including but not limited to Quality Management Review.
- Review and approve procedures, which include, but are not limited to: SOP's, controlled forms, and work instructions.
- Identify and escalate compliance gaps across quality systems.
- Generate and revise standard operating procedures and associated documents as needed.
- Identify compliance risks and escalate the issues to appropriate levels of management for resolution.
- Gather metric information for use in continuous improvement of areas of responsibility and report to management, as needed.
- Support deviation/OOS systems and ensure proper investigation and root cause analysis are performed and corrective actions implemented.
- Support the CAPA system and ensure timely closure and effectiveness of investigations and corrective and preventive actions.
- Support quality assessments of internal operations to analyze compliance and assess risk.
- Review and approve proposed changes to systems, procedures and methods.
- Review and approve deviations, LIRs, OOS, in compliance with SOPs and timelines.
- Develop and manage site inspection readiness and regulatory surveillance program.
- Perform other duties as required.
What you have to offer.
- Bachelors of Science degree with a minimum of 5 years of combined technical experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
- Knowledge of regulatory requirements (eg. 21 CFR Part 11/210/211).
- Minimum of 3 years of working within Quality Systems.
- Strong knowledge of GMPs.
- Strong knowledge of Deviation, OOS, CAPA, Change Management, Auditing practices/strategies.
- Excellent writing and editing skills.
- Works on multiple assignments in collaboration with various department system owners.
- Knowledge with aseptic manufacturing processes.
- Advanced Skills with MS Office applications Word, Excel, Access, PowerPoint as well as Adobe Acrobat.
- Experience in electronic Quality Management Systems, Document Management Systems, and Training Management Systems.
- Ability to communicate and work independently with scientific/technical personnel.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Self-motivated, detail-oriented and comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HRA & 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!