At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
QA CMC Manager - Product Documentation (m/f/d)
YOUR TASKS AND RESPONSIBILITIES
- Global quality CMC expert (m/f/d) for active product ingredients, drug products, combination products, medical devices, excipients and packaging materials and key contact for Global Regulatory Affairs, Manufacturing Sites, Contract Manufacturing, Global Change Management as well as Issue & Complaint Management
- Ensure regulatory compliance and quality requirements are met by checking and approving all Technical Registration Documents (module 3 reports) required for submissions in the frame of new drug applications, change applications/variations, renewals of marketing authorizations, active substance master files, etc. to Health Authorities worldwide, considering all technically, regulatory and legally relevant requirements
- Act as project lead (m/f/d) for cross-functional authoring teams, driving timely finalization of Technical Registration Documents (TRDs/reports) required for new drug applications
- Generate quality overall summaries/expert statements for above mentioned submissions to Health Authorities
- Be responsible for scientific and regulatory consultancy for Health Authorities requests (“deficiency letters”), compliance checks, deviations, audits, etc.
Act as representative (m/f/d) for Product Documentation and/or Quality Assurance in strategic projects or other initiatives
WHO YOU ARE
- University degree in pharmacy or similar qualification, PhD preferred
- Several years of professional experience in the pharmaceutical industry (e.g. in pharmaceutical production, quality control, development, regulatory affairs) and/or within the GMP environment
- Advanced scientific and technical expertise in the area of CMC, GMP and/or regulatory affairs
- Very good project management skills and the ability to focus on multiple issues at one time, and to organize and direct diverse activities in a changing environment
- Independent working style paired with analytical thinking
- Strong teamwork and communication skills to discuss complex scientific topics in a global environment and to develop solutions
- Business fluent in English, both written and spoken
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Reference Code: 389681
Functional Area: Quality