Responsible Person, Director Corporate Quality (20%) (m/f/d)
Job ID: 12442
Entourage is a life sciences consulting firm headquartered in Munich, with additional offices in Basel, Milan, and Boston. The company features a multidisciplinary team of over 180 industry-experienced consultants who collaborate closely with leaders in the pharmaceutical and medical products industries to develop tailored solutions. Leveraging its unique hybrid approach, which combines project and management consulting, Entourage is able to offer its clients individualized solutions in the life sciences sector.
Our client, a small-sized commercial pharmaceutical company in the Zug area, is looking for a consultant or freelancer:
The responsible person is an independent person from the management’s decisions who fulfill all tasks of a Responsible Person, according to the technical interpretation of Swissmedic and to the European Commission Guidelines on Good Distribution Practice of medicinal products for human use which have been incorporated into the Swiss law.
Those tasks include:
- ensuring that a quality management system is implemented and maintained
- focusing on the management of authorized activities and the accuracy and quality of records
- ensuring that initial and continuous training programs are implemented and maintained
- coordinating and promptly performing any recall operations for medicinal products
- ensuring that all kinds of complaints are dealt with effectively
- ensuring that suppliers and customers are approved
- approving any subcontracted activities which may impact on GDP
- ensuring that self-inspections are performed at appropriate regular intervals
- a prearranged program and necessary corrective measures are put in place
- keeping appropriate records of any delegated duties
- deciding about release or rejection of products for the market, independently of the management’s decisions
- deciding on the final disposition of returned, rejected, recalled or falsified products
- approving any returns to salable stock
- leading periodic management review activities
This person also performs tasks as a Director of Corporate Quality:
- Preparing and maintaining corporate policies compliant to the EU and Swiss regulations and guidance and to the national requirements
- Harmonizing the local quality systems according to the above-mentioned corporate policies
- Supervising and monitoring the distribution (GDP) activities of each site
- Supporting EU serialization activities according to effective SOPs
- Life Science degree (Medical, Pharmacy, or equivalent)
- At least 5–6 years of quality experience, showcasing a comprehensive skill set for a senior pharmacovigilance professional.
- The ideal candidate will have in-depth knowledge and expertise across all quality fields.
- Understanding of GDP (Good Distribution Practice) and supply chain.
- Experience of supporting health authority inspections, particularly with Swiss Medic. Conducting and overseeing audits within quality sector. Comprehensive understanding of inspection processes.
- Skills in team management, logical thinking, critical and pragmatic problem-solving abilities.
- Proficient in English and German, with exceptional communication and interpersonal skills for effective team engagement.
- Schweiz
- Pharma
- Qualitätsmanagement
- kathrin.vernice@theentourage.ch
- +41615118931
- +41799270924
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