Senior Manager, GDE SOP Excellence
About The Position
As a Senior Manager, GDE SOP Excellence, you will play a pivotal role in shaping and optimizing the procedural framework that supports BioNTech’s Global Development Organization (GDO). Your leadership will ensure that our Standard Operating Procedures (SOPs) and related documentation align with regulatory requirements, enabling operational excellence and supporting our mission to revolutionize medicine. In this role, you'll collaborate with cross-functional teams to drive SOP governance, streamline processes, and promote a culture of quality and continuous improvement. Your work will directly contribute to the success of our clinical development efforts while fostering innovation within a dynamic and inclusive environment.
Requirements
- Bachelor's degree in Life Sciences, Healthcare, Business Administration, Regulatory Affairs, or related discipline with 5+ years of relevant experience in SOP governance, quality systems, clinical development, clinical operations, regulatory affairs, process excellence, or related functions within the pharmaceutical, biotechnology, or healthcare industry.
- Strong understanding of Good Clinical Practice (GCP), quality systems, and document governance principles
- Proven leadership skills with the ability to influence stakeholders across all organizational levels
- Excellent technical writing capabilities paired with strong analytical and problem-solving skills
- Proficiency in tools like Microsoft Office Suite, SharePoint, and process mapping software (e.g., Visio)
Responsibilities
- Lead the development, harmonization, and continuous improvement of SOPs, work instructions, and procedural documents across GDO
- Establish robust SOP governance processes while ensuring compliance with regulatory requirements and industry standards
- Partner with functional leaders to identify process improvement opportunities and translate them into effective procedural documentation
- Drive alignment on procedural changes through collaboration with cross-functional teams and governance forums
- Monitor SOP effectiveness using performance metrics and inspection findings to recommend improvements
- Champion a culture of quality, knowledge sharing, and operational excellence within the organization
Benefits
- 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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
