What are the responsibilities and job description for the Manager, Quality Systems and Compliance position at BioNTech SE?
Gaithersburg, US | full time | Job ID: 8844
We are seeking a highly motivated individual to join us as Manager, Quality Systems and Compliance to manage the activities of the site Quality Systems and Compliance Team in our new research and clinical production facility.
Responsibilities (include but are not limited to):
Requirements:
BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30 hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:
Expected Pay Range: $120,000/year to $150,000/year benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.
Located in the BioHealth Capital Region near Washington DC and ranked among the top biopharma hubs in the country, Gaithersburg, Maryland offers a unique and diverse cluster across industry, government, and academia for top talent and scientific innovation. As a pivotal player within the life sciences community, Gaithersburg is distinguished by its robust infrastructure and strategic location near the nation’s capital. The city’s strategic significance is amplified by its state-of-the-art manufacturing facilities that cater to the rigorous demands of the life sciences industry; Gaithersburg’s manufacturing sector is defined by advanced technologies and complies with the most stringent regulatory standards, ensuring the production of high-quality pharmaceuticals, biologics, and medical devices. In the coming years, Gaithersburg will continue to be a vital contributor to the future of medical science and technology.
Apply now - We look forward to your application!
Apply for our Gaithersburg, US location and simply send us your documents using our online form.
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are seeking a highly motivated individual to join us as Manager, Quality Systems and Compliance to manage the activities of the site Quality Systems and Compliance Team in our new research and clinical production facility.
Responsibilities (include but are not limited to):
- Manage Quality Systems staff including recruitment, performance management, hiring along with staff training and development.
- Oversees site training, documentation and all other elements of the pharmaceutical quality system (eg. CAPA, Deviation, Change Control, Management Review Board, Audit/Inspection Program, Training, Documentation and Risk Management).
- Develops and implements local Quality Systems.
- Manage interactions with country affiliates and Qualified Persons.
- Participate in FDA, EMA, Health Canada and other regulatory board of health inspections at the site.
- Manage internal and external site audits ensuring adherence to audit schedule and timely closure of findings.
- Chairs the site Quality Management Review.
- Maintain and reports monitoring and control metrics for site quality systems, process performance and product quality.
- Participate and provide leadership at the site level and at the global level, as required.
- Liaise with global process teams as the GB site Quality System representative.
Requirements:
- Bachelor’s degree in the biological sciences or related field
- Minimum of 8 years’ progressive quality or manufacturing experience in a pharmaceutical or biologics operation
- Working knowledge and ability to apply GMP in conformance to U.S., EU, and ROW standards
- Demonstrated ability to develop, coach, and mentor key employees
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Demonstrated ability to think in a risk-based manner commensurate with clinical GMP production systems
- Master’s Degree
- Biologics or vaccines experience
- Minimum of 2 years in Quality Systems
- Minimum of 3 years of management/leadership experience
BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30 hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:
- Medical, Dental and Vision Insurance
- Life, AD&D, Critical Illness Insurance
- Pre-tax HSA & FSA, DCRA Spending Accounts
- Employee Assistance & Concierge Program (EAP) available 24/7
- Parental and Childbirth Leave & Family Planning Assistance
- Parental and Childbirth Leave & Family Planning Assistance
- Sitterstream: Virtual Tutoring & Childcare Membership
- Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
- 401(K) Plan with Company Match
- Tuition Reimbursement & Student Loan Assistance Programs
- Wellbeing Incentive Platforms & Incentives
- Professional Development Programs
- Commuting Allowance and subsidized parking
- Discounted Home, Auto & Pet Insurance
Expected Pay Range: $120,000/year to $150,000/year benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.
Located in the BioHealth Capital Region near Washington DC and ranked among the top biopharma hubs in the country, Gaithersburg, Maryland offers a unique and diverse cluster across industry, government, and academia for top talent and scientific innovation. As a pivotal player within the life sciences community, Gaithersburg is distinguished by its robust infrastructure and strategic location near the nation’s capital. The city’s strategic significance is amplified by its state-of-the-art manufacturing facilities that cater to the rigorous demands of the life sciences industry; Gaithersburg’s manufacturing sector is defined by advanced technologies and complies with the most stringent regulatory standards, ensuring the production of high-quality pharmaceuticals, biologics, and medical devices. In the coming years, Gaithersburg will continue to be a vital contributor to the future of medical science and technology.
Apply now - We look forward to your application!
Apply for our Gaithersburg, US location and simply send us your documents using our online form.
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
Salary : $120,000 - $150,000
