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BI
BioNTech SE
yesterday

Manager QA Compliance(m/w/x)

Mainz
Full-timeOn-siteSenior

Description

In this role, you will safeguard global compliance by managing the QMS and process landscape. You'll drive operational excellence through strategic partner collaboration and expert GMP guidance.

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Requirements

  • Degree in Pharmacy, Chemistry, Biology, or related field
  • Advanced degrees (MSc, PhD) as a plus
  • Extensive experience in Quality Assurance and GMP
  • Management of MAH/Sponsor responsibilities and QMS
  • Knowledge of GMP, ICH Q10, and regulations
  • Exceptional communication and networking skills
  • Excellent written and verbal English skills
  • Analytical mindset and compliance problem-solving ability

Education

Bachelor's degree
OR
Master's degree

Work Experience

5 years

Tasks

  • Oversee the global MAH and Sponsor QMS footprint
  • Design and optimize the compliance process landscape
  • Advise strategic partners on complex GMP matters
  • Organize and support Quality forums and committees
  • Provide compliance guidance to internal stakeholders
  • Improve quality systems per GMP and ICH guidelines
  • Represent the company to ensure regional compliance
  • Implement board processes for evaluating quality metrics
  • Report on trends and mitigate compliance risks
  • Coordinate and support regulatory inspections and audits

Tools & Technologies

GMP complianceQMS frameworksICH Q10

Languages

EnglishBusiness Fluent

Benefits

Flexible Working

  • Flexible hours

More Vacation Days

  • Vacation account

Learning & Development

  • Digital Learning
  • LinkedIn Learning

Career Advancement

  • Performance and talent development
  • Leadership development

Other Benefits

  • Apprenticeships

Informal Culture

  • Culture on an equal footing

Purpose-Driven Work

  • Opportunities to shape and impact

Mentorship & Coaching

  • Support for your full potential

Company Bike

  • Company bike

Public Transport Subsidies

  • Job ticket
  • Deutschlandticket

Retirement Plans

  • Employer-funded pension

Childcare

  • Childcare
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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