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Associate Director Supply Chain Compliance - Job Opportunity at BioNTech AG

Mainz, Germany
Full-time
Senior
Posted: June 5, 2025
On-site
EUR 85,000 - 110,000 annually based on German pharmaceutical industry standards for Associate Director level positions, with BioNTech's market position and the specialized nature of supply chain compliance in biotechnology typically commanding premium compensation within this range

Benefits

Company bike leasing program providing sustainable transportation options and promoting employee wellness while reducing commuting costs
Flexible working hours enabling optimal work-life balance and increased productivity through personalized scheduling
Public transportation subsidies including job tickets and Deutschlandticket reducing commuting expenses and supporting environmental sustainability
Comprehensive professional development ecosystem including digital learning platforms, performance management, leadership development programs, apprenticeships, and LinkedIn Learning access
Employer-funded pension contributions securing long-term financial stability and retirement planning
On-site childcare services supporting working parents and reducing external childcare costs
Vacation account system providing flexible time-off management and potential financial benefits

Key Responsibilities

Lead and develop a specialized Supply Chain Compliance team ensuring adherence to critical GxP regulations, directly impacting product quality and regulatory approval processes in the biotechnology sector
Serve as functional leader managing SC compliance experts and driving strategic alignment between Quality Assurance and Supply Chain Management departments
Orchestrate timely execution of quality-critical measures including deviation management, change control processes, and corrective/preventive action implementation that directly affects product safety and regulatory compliance
Create and manage lifecycle of essential training documentation including Standard Operating Procedures and Work Instructions that establish organizational compliance standards
Support qualification and validation activities for supply chain materials, equipment, facilities, software systems, and service partnerships ensuring regulatory compliance across all operational elements
Serve as single point of contact for audit readiness, preparation, and participation, representing the organization's compliance posture to regulatory authorities
Drive project execution for product launches, claims management, and risk analysis implementation while establishing globally aligned standards through BioNTech's electronic Quality Management System

Requirements

Education

Bachelor's degree in a related field, with a focus on Compliance or Quality. Master's degree preferred.

Experience

Minimum of 5 years of Compliance experience in Supply Chain Management, Logistics, or Manufacturing environments, with at least 3 years in a leadership role

Required Skills

In-depth understanding of GxP (GMP, GDP) processes and compliance standards Excellent communication and interpersonal skills, with the ability to build strong relationships with stakeholders at all levels Strong analytical and problem-solving skills, able to identify and resolve complex issues Hands-on mentality with ownership of tasks, seeing them through to completion Ability to work independently within general conditions such as budget and project milestones Fluency in German and English, both oral and written
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Sauge AI Market Intelligence

Industry Trends

The biotechnology and pharmaceutical industry is experiencing unprecedented regulatory scrutiny following recent global health events, driving demand for specialized compliance professionals who can navigate complex GxP requirements while maintaining operational efficiency. Companies are investing heavily in compliance infrastructure to ensure product quality and regulatory approval timelines. Digital transformation in pharmaceutical supply chains is accelerating, requiring compliance professionals to understand electronic quality management systems, data integrity requirements, and digital validation processes. The integration of AI and automation in manufacturing processes demands new compliance frameworks and expertise. Global supply chain resilience has become a strategic priority for pharmaceutical companies, with increased focus on supplier qualification, risk management, and business continuity planning. Compliance professionals are now expected to contribute to strategic supply chain decisions and risk mitigation strategies.

Role Significance

Typically manages a team of 3-8 compliance specialists and coordinates with broader supply chain and quality assurance teams totaling 20-40 professionals across multiple functional areas
Senior management position with significant cross-functional influence and decision-making authority, serving as a bridge between operational supply chain activities and regulatory compliance requirements. The role carries substantial responsibility for organizational risk management and regulatory relationships.

Key Projects

Implementation of electronic Quality Management System upgrades and digital compliance workflows Cross-functional supply chain risk assessments and business continuity planning initiatives Regulatory audit preparation and response coordination for health authority inspections New product launch compliance validation and documentation management Global supplier qualification and ongoing compliance monitoring programs

Success Factors

Deep technical expertise in GxP regulations combined with practical understanding of pharmaceutical manufacturing and supply chain operations, enabling effective translation of regulatory requirements into operational procedures Strong leadership and change management capabilities to drive compliance culture across diverse teams and influence stakeholders at all organizational levels without direct authority Strategic thinking ability to anticipate regulatory trends and proactively adapt compliance frameworks while balancing operational efficiency with regulatory requirements Exceptional communication skills to serve as liaison between technical teams, regulatory authorities, and senior management, effectively communicating complex compliance concepts to diverse audiences

Market Demand

High demand driven by expanding pharmaceutical manufacturing capacity, increasing regulatory complexity, and the critical nature of supply chain compliance in ensuring product quality and patient safety in the post-pandemic healthcare landscape

Important Skills

Critical Skills

GxP regulatory expertise is absolutely essential as it forms the foundation for all compliance activities and regulatory interactions. Deep understanding of GMP and GDP requirements directly impacts product quality, patient safety, and company regulatory standing with health authorities. Leadership and cross-functional collaboration skills are critical given the role's responsibility for influencing diverse teams without direct authority and serving as the primary interface between supply chain operations and quality assurance functions. Analytical and problem-solving capabilities are essential for identifying compliance risks, developing mitigation strategies, and resolving complex regulatory issues that could impact product availability and company reputation.

Beneficial Skills

Project management certification (PMP) would enhance ability to manage complex compliance initiatives across multiple functional areas and global locations Advanced degree in regulatory science or pharmaceutical sciences would provide deeper technical foundation for emerging biotechnology compliance challenges Experience with digital quality management systems and data integrity frameworks would be valuable given the industry's digital transformation trajectory German and European regulatory expertise would be particularly valuable for navigating regional regulatory requirements and health authority relationships

Unique Aspects

Fixed-term contract structure due to parental leave coverage provides opportunity for immediate senior-level responsibility with potential for permanent placement based on performance and organizational needs
Direct involvement in supply chain compliance for cutting-edge biotechnology products including mRNA vaccines and immunotherapy treatments, offering exposure to novel regulatory challenges and emerging compliance frameworks
Position within a company that has demonstrated ability to rapidly scale manufacturing and regulatory compliance capabilities, providing unique experience in managing compliance during hypergrowth phases
Opportunity to work with globally distributed supply chains for life-saving medical products, combining traditional pharmaceutical compliance with innovative biotechnology manufacturing processes

Career Growth

3-5 years to VP level with demonstrated success in compliance leadership and regulatory relationship management, potentially accelerated given the rapid growth and expansion in the biotechnology sector

Potential Next Roles

Vice President of Quality Assurance or Regulatory Affairs Head of Global Supply Chain Compliance Chief Compliance Officer Director of Regulatory Strategy

Company Overview

BioNTech AG

BioNTech AG is a German biotechnology company that gained global prominence through its COVID-19 vaccine development partnership with Pfizer, representing one of Europe's most successful biotech companies with significant research and development capabilities in immunotherapy and infectious disease prevention.

Leading European biotechnology company with strong financial position, extensive research pipeline, and established partnerships with major pharmaceutical companies, positioning it as a key player in the global biotechnology landscape
This role represents a strategic position within BioNTech's German headquarters operations, offering exposure to global supply chain management while being central to the company's European manufacturing and regulatory strategy
Innovation-driven environment with emphasis on scientific excellence, regulatory rigor, and cross-functional collaboration, typical of successful biotechnology companies balancing rapid growth with pharmaceutical industry compliance requirements
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