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BI
BioNTech SE
last mo.

Executive Director Modality (Product) Quality Assurance(m/w/x)

Mainz
Full-timeOn-siteSenior

Description

In this role, you will lead product development within a Quality Management System, ensuring compliance with key regulations while driving innovation. Your day-to-day responsibilities will involve guiding teams, managing product changes, and fostering a culture of excellence.

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Requirements

  • Degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field
  • Advanced degrees (e.g., MSc, PhD, MBA) highly desirable
  • Extensive experience in pharmaceutical product development, Quality Assurance, and GMP compliance
  • Proven track record of leading product lifecycle management and strategic initiatives
  • Deep understanding of ICH guidelines (Q8, Q9, Q10) and their application
  • Excellence in understanding product challenges with a focus on compliance and risk management
  • Proven ability to lead and develop teams, fostering collaboration and accountability
  • Excellent communication and escalation skills for managing product deviations
  • Exceptional analytical and problem-solving skills for complex product development challenges

Education

Bachelor's degree
OR
Master's degree

Work Experience

approx. 4 - 6 years

Tasks

  • Develop a data-driven approach to product development
  • Establish a governance model based on risk management principles
  • Lead modality-specific teams in technology-driven divisions
  • Ensure accountability and strategic direction for modality leads
  • Drive collaboration and innovation in specialized areas
  • Oversee critical product changes for regulatory compliance
  • Guide product changes related to quality, safety, and efficacy
  • Manage critical product deviations impacting compliance and quality
  • Lead and develop a team of Quality Assurance professionals
  • Foster a culture of collaboration and accountability within the team
  • Empower teams to align with organizational priorities and compliance standards

Languages

EnglishBusiness Fluent

Benefits

Flexible Working

  • Flexible hours

More Vacation Days

  • Vacation account

Learning & Development

  • Digital learning
  • Apprenticeships
  • LinkedIn Learning

Career Advancement

  • Performance development
  • Leadership development

Other Benefits

  • Your voice at the table
  • Support for your full potential

Informal Culture

  • Culture on an equal footing

Purpose-Driven Work

  • Opportunities to shape & impact

Company Bike

  • Company bike

Public Transport Subsidies

  • Job ticket
  • Deutschlandticket

Retirement Plans

  • Employer-funded pension

Childcare

  • Childcare
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