Audit-Jobs in Deutschland

We are seeking an experienced and dynamic Project Manager to lead and drive key cross-functional projects within our biopharmaceutical portfolio. The ideal candidate will be responsible for planning executing and closing projectsranging from early research programs to process development and tech transferensuring they are delivered on time within scope and in compliance with regulatory standards (GMP / GCP) and company objectives. This role requires exceptional leadership strategic thinking and a deep understanding of the biopharma development lifecycle.

• Project Leadership & Strategy :
• Lead cross-functional project teams (e.g. R&D Regulatory CMC Clinical Manufacturing QA) to define project scope goals and deliverables.
• Develop and maintain integrated project plans timelines budgets and risk management strategies.
• Facilitate decision-making and ensure clear communication of project status risks and mitigation plans to senior management and stakeholders.
• Execution & Delivery :
• Drive day-to-day project execution ensuring adherence to milestones and budget.
• Proactively identify assess and manage project risks issues and changes; implement effective corrective actions.
• Manage relationships with external partners & Clients (e.g. CROs CDMOs) as required by the project.
• Compliance & Quality :
• Ensure all project activities align with relevant regulatory requirements (FDA / EMA GMP GCP GLP) company SOPs and quality standards.
• Support the preparation of regulatory submissions and audits as needed.
• Communication & Reporting :
• Serve as the primary point of contact for project information internal and external.
• Prepare and present clear concise project updates dashboards and steering committee materials.
• Foster a collaborative and accountable team environment.

• Education :
• Bachelors degree in Life Sciences Engineering Pharmacy or related field. Advanced degree (MS MBA PhD PMP) is a strong plus.
• Experience :
• Minimum of 5 years of project management experience within the biopharmaceutical or biotechnology industry.
• Proven track record of successfully managing complex cross-functional projects (e.g. drug development programs process validation facility start-up tech transfer).
• Solid understanding of drug development lifecycle (from discovery to commercialization) and regulatory environments (CMC non-clinical clinical).
• Hands-on experience with project management tools (e.g. MS Project Smartsheet) and methodologies.
• Professional Certification (Preferred) :
• Project Management Professional (PMP) certification or equivalent.

• Leadership & Influence : Ability to lead without direct authority motivate teams and drive outcomes in a matrix environment.
• Strategic & Financial Acumen : Strong business and financial skills to manage budgets and understand project value.
• Problem-Solving : Excellent analytical and risk management skills.
• Communication : Outstanding verbal and written communication and presentation skills.
• Adaptability : Ability to thrive in a fast-paced science-driven and ambiguous environment.
• Attention to Detail : Rigorous and organized with a focus on quality and compliance.

• A pivotal role in shaping the future of our therapeutic pipeline.
• Competitive compensation package including performance bonus and equity.
• Comprehensive health and wellness benefits.
• Opportunities for professional growth and development.
• A collaborative and innovative work culture.