CMC Documentation Manager | CMC Documentation Manager (m/w/d)
Office Events P & B GmbH
Job Summary
As a CMC Documentation Manager, you will be responsible for the technical writing and preparation of Chemistry, Manufacturing, and Controls (CMC) quality documentation for global pharmaceutical products. Working in close collaboration with Regulatory Affairs CMC and subject matter experts across manufacturing sites, you will ensure the on-time delivery of technical documents required for variations, renewals, geographical extensions, and responses to regulatory questions. This role involves managing complex scientific data and translating it into compliant documentation aligned with international templates and processes. The position is highly attractive due to its international scope, the opportunity to work for a major industrial player in the Mainz-Bingen region, and a competitive compensation package under the chemical industry collective agreement. Additionally, the role offers a modern work environment with home office options (2-3 days per week), an on-site fitness studio, and a company restaurant.
Required Skills
Education
Master's degree (e.g., MBA, MSc) or equivalent with a major focus on pharmaceutics, chemistry, or other natural sciences.
Experience
- Several years of industry experience with international exposure in pharmaceutical or chemical development, production, or analytical sciences.
- Proven operational experience in the preparation and review of analytical and manufacturing documentation regarding scientific issues.
- Professional experience in Regulatory Affairs, Quality Control, or Quality Assurance departments.
- Demonstrated ability to work independently in multi-disciplinary and international project teams.
Languages
Additional
- The position is initially limited until February 28, 2027, with an option for extension or permanent takeover. Mobile work is available 2-3 days per week. The role is located in the Mainz-Bingen district.
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