Associate Director Quality Assurance, Rp

vor 2 Wochen

Basel, Schweiz Proclinical Vollzeit

Proclinical are recruiting an Associate Director Quality Assurance, RP for a biotech corporation. This role is on a permanent basis and is located in Basel. The client is focused on creating, producing and commercialising transformative medicines for those who are suffering from serious illnesses.

**Responsibilities**:

- Handle local recall actions and implementation/contribution in periodic mock product recall challenges.
- Responsible for supplier management and supplier audits which involve distribution associates within Switzerland.
- You will draft and renew quality agreements with both internal manufacturers and/or external associates.
- Ensure the executed quality management system is consistently updated.
- Accountable for shipping medicinal products rendering to the GDP rules/guidelines.
- Manage QA evaluation of local affiliate change controls, deviations & CAPAs.
- Examine annual periodic product reviews rendering to the Swiss marketing authorisation.
- You will host inspections by the cantonal authorities and Swissmedic and corporate GDP/GMP audits.
- Other duties may be assigned to this role.

**Key Skills and Requirements**:

- Educated to a degree level in a pharmacy, chemistry, biotechnology or any other natural scientific field.
- Familiarity within a global setting with know-how of both global and local quality systems and guidelines and standards for pharmaceutical products and medical devices.
- Acquaintance with serving as a responsible person or as a deputy.
- At least 5+ years of experience within a QA role, of which at least 2 of those years were within the Swiss market.
- Influential and deliberation abilities.
- Leadership skills.
- A high attention to detail and precision.
- Works well in a team as well as independently.
- Works well under pressure with a reliable approach to work.
- Communication skills both verbally and in writing.
- Identified as an expert resource for advice within other divisions.
- Fluency in the German language with knowledge in English, as well as knowledge in French and/or Italian would be beneficial.
- Willing to travel for business needs up to 10% of the time.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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