Pharmaceutical company needs reinforcement.
Our customer, a pharmaceutical company based in Basel, needs reinforcement. For a temporary employment (duration: 1 year) we are looking for a
Senior Quality Manager (m/f), 100%
- Provide QA oversight on all external suppliers. Manage supplier qualifications, supplier changes, and quality agreements. Assure compliance to cGMP standards is maintained for third party management.
- Responsible for initiating and driving supplier qualifications
- Upgrade of supplier qualifications from clinical to commercial in scope of going commercial project
- Upgrade of raw materials and consumables from clinical to commercial in scope of the going commercial project
- Oversight on all suppliers and raw materials used
- Manage quality aspects at external suppliers and ensure their compliance with good manufacturing practice
- Manage and evaluate change notifications from external suppliers
- Write GMP relevant documents in area of responsibility (SOPs, Quality Agreement, APS) and ensure implementation at third parties
- Perform local implementation of Quality Manual and global procedures (gap assessment, local changes in SOPs…)
- Minimum: Basic degree in scientific or relevant discipline (BS or equivalent)
- Desirable: Advanced degree in scientific or relevant discipline (MS or equivalent)
- Fluent in English (oral and written) required; fluent in site-language desirable
- At least 3 years of relevant experience.
- Strong ability to negotiate and communicate.
- Good team working skills
- Sound scientific, technical and regulatory knowledge.
- Excellent knowledge of cGMPs, working knowledge of safety and environmental regulations and guidelines.
- Good knowledge of drug development and drug substance production.
- Good organizational skills.
- Good and proven ability to analyze and evaluate GMP compliance.
In case of any question, please don’t hesitate to contact Renato Imboden at 061 269 90 60.