Compliance jobs in Germany

Mainz, Germany | full time | Job ID: 8562

We are seeking a highly motivated and experienced Site Head (m/f/d) for our clinical manufacturing site for individualized cancer vaccines. The position is responsible for managing strategic alignment with platform targets, business execution on timelines, capacities and budget. Leadership of all local departments (manufacturing, site engineering, quality control) and alignment with R&D and the future commercial site. The Site Head will also be responsible for ensuring compliance with all regulatory requirements and for maintaining a safe and efficient work environment.

Responsibilities:

• Lead and manage the Clinical production team, including production, site engineering, and quality control personnel
• Develop and implement production plans to ensure timely delivery of clinical trial materials
• Ensure compliance with all regulatory requirements, including cGMP, FDA, and EMA regulations
• Oversee the development and optimization of production processes to improve efficiency and reduce costs
• Collaborate with cross-functional teams to ensure alignment of production activities with clinical development plans and collaboration partners
• Manage relationships with external vendors and partners to ensure timely delivery of materials and services
• Ensure a safe and efficient work environment, including compliance with all safety regulations and procedures
• Develop and manage the site budget, including capital expenditures and operating expenses

Requirements:

• Master`s degree in a scientific or engineering discipline
• Minimum of 10 years of experience in clinical manufacturing operations, including at least 5 years in a leadership role
• Extensive knowledge of cGMP, FDA, and EMA regulations, ATMP experience preferred
• Strong leadership and management skills, with a demonstrated ability to lead cross-functional teams
• Excellent communication and interpersonal skills, with the ability to build strong relationships with internal and external stakeholders
• Strong problem-solving and decision-making skills, with the ability to think strategically and tactically
• Experience managing budgets and financial performance

If you are a strategic thinker with a passion for innovation and a proven track record of success in shaping the organization and deliver on targets, we encourage you to apply for this exciting opportunity.

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 12 PM to 4 PM CET).

Job ID 8562 (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.

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