Manager Quality Intelligence & Strategy
BioNTech SE
4 months ago
Remote friendly (Cambridge, MA)
United States
$113,600 - $181,600 USD yearly
Operations
Responsibilities:
- Establish, implement, and continuously improve a Global Quality Assurance (QA) oversight framework to ensure GMP/GDP compliance for MAH and Sponsor-related activities globally.
- Design, maintain, and optimize the process landscape to support compliance and operational excellence.
- Support discussions and decision-making with strategic partners on complex GMP/compliance topics; coordinate and prepare documentation; organize/assist Quality forums and governance committees.
- Provide guidance to cross-functional stakeholders to promote a strong Quality culture; communicate, advise peers, and collaborate across the network.
- Contribute to continuous improvement of the Pharmaceutical Quality System in accordance with EU GMP Guide Chapter 1, ICH Q10, and applicable regulations.
- Ensure regional and global compliance as an MAH/Sponsor representative by addressing evolving regulatory expectations.
- Implement new processes to strengthen MAH/Sponsor oversight and improve visualization, transparency, and sharing of key Quality information.
- Lead and support Quality Board processes by evaluating Quality metrics, trends, and compliance data to enable informed decisions and continuous improvement.
- Maintain, analyze, and report Quality metrics; identify risks and implement mitigation strategies.
- Support inspections and audits: preparation, coordination, follow-up, inspection readiness, and subject matter expertise during regulatory interactions.
Qualifications:
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or related scientific discipline.
- Minimum 5 years’ experience in Quality Assurance, GMP compliance, and regulatory processes in the pharmaceutical industry.
- Demonstrated experience managing MAH/Sponsor responsibilities and Quality Management System (QMS) frameworks.
- Strong knowledge of GMP guidelines, ICH Q10, 21 CFR Part 211, and relevant regional/national regulatory requirements.
- Excellent written and verbal communication skills in English; strong analytical and problem-solving skills; ability to influence and work effectively across teams.
Preferred Qualifications:
- Advanced degrees (MSc, PhD).
Benefits:
- Medical, Dental and Vision Insurance; Life, AD&D, Critical Illness Insurance; Pre-tax HSA/FSA and DCRA Spending Accounts; EAP (24/7); Parental and Childbirth Leave & Family Planning Assistance; Sitterstream; Paid Time Off; 401(K) Plan with Company Match; Tuition Reimbursement & Student Loan Assistance; Wellbeing incentives; Professional Development Programs; Commuting allowance and subsidized parking; Discounted Home/Auto/Pet Insurance.
Application Instructions:
- Apply for the Cambridge, US location and submit documents via the online application form.
- Establish, implement, and continuously improve a Global Quality Assurance (QA) oversight framework to ensure GMP/GDP compliance for MAH and Sponsor-related activities globally.
- Design, maintain, and optimize the process landscape to support compliance and operational excellence.
- Support discussions and decision-making with strategic partners on complex GMP/compliance topics; coordinate and prepare documentation; organize/assist Quality forums and governance committees.
- Provide guidance to cross-functional stakeholders to promote a strong Quality culture; communicate, advise peers, and collaborate across the network.
- Contribute to continuous improvement of the Pharmaceutical Quality System in accordance with EU GMP Guide Chapter 1, ICH Q10, and applicable regulations.
- Ensure regional and global compliance as an MAH/Sponsor representative by addressing evolving regulatory expectations.
- Implement new processes to strengthen MAH/Sponsor oversight and improve visualization, transparency, and sharing of key Quality information.
- Lead and support Quality Board processes by evaluating Quality metrics, trends, and compliance data to enable informed decisions and continuous improvement.
- Maintain, analyze, and report Quality metrics; identify risks and implement mitigation strategies.
- Support inspections and audits: preparation, coordination, follow-up, inspection readiness, and subject matter expertise during regulatory interactions.
Qualifications:
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or related scientific discipline.
- Minimum 5 years’ experience in Quality Assurance, GMP compliance, and regulatory processes in the pharmaceutical industry.
- Demonstrated experience managing MAH/Sponsor responsibilities and Quality Management System (QMS) frameworks.
- Strong knowledge of GMP guidelines, ICH Q10, 21 CFR Part 211, and relevant regional/national regulatory requirements.
- Excellent written and verbal communication skills in English; strong analytical and problem-solving skills; ability to influence and work effectively across teams.
Preferred Qualifications:
- Advanced degrees (MSc, PhD).
Benefits:
- Medical, Dental and Vision Insurance; Life, AD&D, Critical Illness Insurance; Pre-tax HSA/FSA and DCRA Spending Accounts; EAP (24/7); Parental and Childbirth Leave & Family Planning Assistance; Sitterstream; Paid Time Off; 401(K) Plan with Company Match; Tuition Reimbursement & Student Loan Assistance; Wellbeing incentives; Professional Development Programs; Commuting allowance and subsidized parking; Discounted Home/Auto/Pet Insurance.
Application Instructions:
- Apply for the Cambridge, US location and submit documents via the online application form.