Experienced Quality Assurance Manager (Pharma) 50-100%

HEMEX is committed to changing the future of healthcare by guiding the most promising European startups through each and every step to bring innovative pharmaceuticals, medical devices, and in vitro diagnostics to the market. Headquartered close to the thriving Basel global Life Sciences hub, the goal at HEMEX is to ensure startups have access to a wide range of tailored services, practical solutions, and fundraising support.

This empowers the next generation of transformative discoveries to grow into successful and sustainable businesses, and drive change in both human and animal healthcare.

Tasks

The Quality Assurance Manager will be responsible for ensuring compliance with rigorous requirements of PIC/S and cGxP. Functional responsibilities will include:

• Apply GMP requirements consistently, using quality and compliance knowledge base to mentor customers and other staff to expand compliance knowledge, to support and provide timely responses to Customer queries and communications relating to GMP compliance and batch release (Investigational and commercial).
• Release and certification of products (on behalf of Partner Company) as a Qualified Person (Fachtechnisch verantwortliche Person) for Switzerland (including rest of the world ) and/or the EEA / EU according to current Swiss legislation and the MRA Switzerland EU, relevant current EU. directives/guidelines, and in accordance with the requirements of the respective product Manufacturer s Authorisation (CH / EU / EEA) based on the Quality system of Hemex AG.
• Responsible for external official contacts (Swissmedic, EMA, FDA, etc.) related to questions of batch release/certification and GMP issues.
• Responsible for external contacts with partners regarding quality assurance, inspection, and cGMP.
• Get involved hands-on with teams of innovative new healthcare solutions and consult and guide them through product development.
• Ensures the maintenance and supervision of the Quality Management System of the contractually agreed quality assurance of the partners of Hemex AG, for the supply chain and distribution, in accordance with cGMP (PIC/S guide, 2001/83/EC and 2003/94/EC) and Dir 2013/C343/01 (GDP), taking into account the Dir 2001/20 / EEC (GCP), Annex 16 (GMP guide) and additional relevant regulations.
• Undertake audits in the CH, EU, and third countries to ensure that Sponsor or MA Holder manufacturing sites are operating in general compliance with EU GMP.
• Assistance with regulatory inspections and client audits.
• Keep up-to-date with the requirements of the Medicines Authorities across the CH, EU, and rest of the world (where relevant).

Requirements

• University degree in Pharmacy, or related discipline.
• Eligible to act as a Qualified Person (QP/FvP) for the certification of Marketed Products and Investigational Medicinal Products in accordance with EU directives 2001/83/EC and 2001/20/EC and/or Swiss 812.212.1 MPLO respectively.
• At least 5 years of experience in the EU and/or the US, in the pharmaceutical and biologics industry.
• GMP Audit experience preferably qualified as Lead Auditor.
• Excellent knowledge of international regulatory standards in the areas of pharmaceutical quality, safety, and efficacy.
• Able to fluently communicate in English and German, any additional languages are a plus.
• Be (financial) results-oriented for Hemex and its clients.
• Ability to adapt communication style based on audience and situation.
• Ability to coordinate and network with various stakeholders simultaneously.
• Proactive in identifying potential issues and escalating them accordingly.
• Solution finder with the ability to deal with complex information.
• Dependable with a high sense of responsibility.
• Efficient working style and hands-on entrepreneurial mentality.
• Liaising as Quality Expert between the customer and internal staff.
• Team player who is able and willing to mentor other staff members.
• Interpersonal adaptability with a positive can-do attitude.
• Comfortable collaborating with other functions like RA and Clinical Operations.

Benefits

• Join a small team of multinational, multidisciplinary, highly motivated experts.
• Modern, inclusive, pleasant working environment in a fast-growing, dynamic organization.
• Ability to independently manage your role and responsibilities.
• Opportunity to develop yourself and support start-ups developing highly innovative therapies.
• We re actively building diverse teams and specifically welcome applications people over the age of 50.
• Office-based employment in Liestal (Switzerland), 7min by foot from Liestal SBB train station.

If you meet the described profile, we look forward to receiving your CV in English, including supporting documents.