Senior Manager, GDE SOP Excellence

Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 11705

About the Role:

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, youll 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.

Your Contribution:

• 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

A Good Match:

• Bachelors 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)

At BioNTech, we are more than just a biotechnology company - we are a community of innovators dedicated to translating cutting-edge science into survival. Join us to make an impact on global health while advancing your career in an inclusive environment that values diversity. Apply today to be part of our mission!

Your benefits and remuneration:

Expected Pay Range: $130,800/year to $209,400/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.

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
• 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

…and more! More details to be shared.

Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge's thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.

Apply now - We look forward to your application!

Apply for our Cambridge, US; Gaithersburg, US; New Jersey, 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.