Mainz, Germany | full time | Job ID: 10542
We are seeking a strategic and visionary leader to oversee product development until commercialization within a Quality Management System (QMS) framework, simplifying complexity and driving innovation.
As Executive Director Modality (Product) Quality Assurance, you will provide strategic leadership over the product lifecycle, ensuring compliance with key regulations such as ICH Q8, Q9, and Q10. You will lead modality-specific teams, guide critical product changes, and oversee non-conformances with potential significant regulatory and/or quality impact. Your expertise over the full product lifecycle, within key compliance, and international GMP expectations will be instrumental in driving excellence and ensuring successful product development and commercialization.
Your Responsibilities:
* Build and Lead Data-Driven Product Development Governance: Develop and lead a data- and metric-driven approach to product development, simplifying complexity and establishing a governance model based on sound risk management principles in alignment with ICH Q8, Q9, and Q10
* Lead Modality-Specific Teams: Provide leadership to modality leads, ensuring accountability and strategic direction in technology-driven divisions such as individualized mRNA, proteins, and mRNA for infectious diseases. Drive collaboration and innovation within these specialized areas to meet organizational goals and regulatory expectations
* Guide and Steer Key Product Changes:Oversee and guide critical product changes related to regulatory compliance, quality, safety, efficacy, manufacturing sites, technology transfers, and commercial preparations and launches
* Manage Critical Product Deviations: Steer and manage critical product deviations with potential impacts on regulatory compliance, quality, safety, efficacy, manufacturing sites, technology transfers, and commercial preparations and launches
* Lead and Develop the Team: Provide strong leadership to a team of Quality Assurance professionals, fostering a culture of collaboration, accountability, and excellence. Focus on team development, ensuring teams are empowered to drive their respective areas while maintaining alignment with organizational priorities and compliance standards
What you have to offer:
* A degree in Life Sciences, Pharmacy, Chemistry, Engineering, or a related field. Advanced degrees (e.g., MSc, PhD, MBA) are highly desirable
* Extensive experience in pharmaceutical product development, Quality Assurance and GMP compliance within the pharmaceutical industry
* Proven track record of leading product lifecycle management and strategic initiatives
* Deep understanding of ICH guidelines (Q8, Q9, Q10) and their application in product development and lifecycle management
* Excellence in understanding product challenges with a focus on compliance, GMP expectations, and risk management principles
* Proven ability to lead and develop teams, including modality-specific leads, fostering a culture of collaboration and accountability while driving operational excellence
* Excellent communication and escalation skills, with the ability to effectively manage critical product deviations and regulatory challenges
* Exceptional analytical and problem-solving skills, with the ability to navigate complex product development challenges and drive effective resolutions
Your Benefits:
It's our priority to support you:
* Your flexibility: flexible hours | vacation account
* Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
* Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
* Your health and lifestyle: Company bike
* Your mobility: Job ticket | Deutschlandticket
* Your life phases: Employer-funded pension | Childcare
Apply now - We look forward to your application!
Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).
Job ID 10542 (please always specify if you have any questions)
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.