Top 12970 Mgr validation Jobs

Director, Clinical Technology Oversight Lead
BioNTech AG —Cambridge, MA
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QuickCode Quality Assurance Manager
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Sr Mgr Validation Engineering
Rambus —San Jose, CA
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Validation Lead
Novartis —Durham, NC
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- 5 years
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Computer System Validation Lead / Program Manager
Veeva Systems —Remote
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Manager, GMP Quality
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Radformation —Remote
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Manager, Medical Device Labeling and Operations
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TÜV SÜD —Wakefield, MA
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IQVIA —Atlanta, GA
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Associate Manager / Manager, Project Services - Laboratories (Remote - East Coast)
IQVIA —Marietta, GA
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Endpoint Clinical —Remote
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Director, Clinical Technology Oversight Lead

BioNTech AG -
Cambridge, MA

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Job Details

Full-time
$168,100 - $268,700 a year

Benefits

Health savings account
AD&D insurance
Health insurance
Dental insurance
Flexible spending account
Tuition reimbursement
Paid time off
Parental leave
Employee assistance program
Vision insurance
401(k) matching
Loan assistance
Life insurance
Pet insurance

Qualifications

English

Full Job Description

Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 11055

About the Role:

As Director, Clinical Technology Oversight Lead at BioNTech, you will play a pivotal strategic leadership role in establishing and driving end-to-end governance, oversight and performance management of clinical technology vendors across our global clinical trial portfolio. Your work will ensure clear accountability, inspection readiness, and optimal vendor performance within an increasingly digital and AI-enabled ecosystem. By introducing a centralized governance framework, you will directly contribute to BioNTech’s mission of revolutionizing medicine and advancing science to improve health worldwide.

Imagine yourself at the forefront of innovation, collaborating across departments such as Clinical Operations, Digital/IT, Procurement, and Quality Assurance to create scalable solutions that enhance trial delivery reliability and compliance. Your leadership will guide vendor performance and risk management while embedding cutting-edge AI governance frameworks into our processes.

Your Contribution:

Design and implement a global Clinical Technology Vendor Governance Framework aligned with ICH GCP E6 R3 and regulatory standards.
Oversee day-to-day vendor performance for technologies like EDC, eCOA, RTSM, eTMF, RBM, digital health solutions, and AI-driven systems.
Define KPIs, SLAs, and metrics tied to study timelines, data quality, system performance, and delivery reliability.
Establish robust AI governance frameworks ensuring transparency in intended use, decision boundaries, risk classification, validation processes, and lifecycle management.
Proactively manage risks through monitoring systems while maintaining inspection readiness for regulatory audits.
Serve as the central escalation point for issue resolution across internal teams and external vendors.
Drive strategic oversight of technology vendors to optimize scalability and cost-efficiency while fostering trust-based partnerships.

A Good Match:

Relevant degree in Vendor Management, Clinical Operations, Business Administration, Program Management or related discipline with12 years of clinical technology management experience with expertise in clinical trial technologies (EDC/eCOA/RTSM/eTMF/RBM/digital health) and AI/ML applications in trials.
Strong understanding of system architectures (APIs/data flows), cloud-based platforms (SaaS models), AI/ML fundamentals (bias/drift/validation), vendor oversight (SLAs/performance), and computerized system validation expectations.
Proven ability to translate complexity into clear governance structures while managing interdependencies across systems/processes.
Exceptional interpersonal skills with experience influencing stakeholders in matrix environments; fluency in English is required; German is advantageous.
Resilience in overcoming challenges coupled with agility to adapt to dynamic circumstances.

Your benefits and remuneration:

Expected Pay Range: $168,100/year to $268,700/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.

Inspired? Become part of #TeamBioNTech.

BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

BioNTech - As unique as you

www.biontech.com

Apply Now

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