Manager Quality Assurance (m/f/d)

In the business unit Pharma we develop generic drugs. The Swiss Hub in Zürich (HELM Swiss GmbH)  is responsible for the commercial and quality handling of a selection of products for export from Switzerland, including the USA.  We are looking to add to our team a Scientist with international experience, in the function of Quality Assurance Manager (m/f/d).

Your tasks:

• Your role involves maintaining, documenting, and enhancing pharmaceutical quality systems to preserve approvals as a distribution and release site for finished dosage pharmaceutical products.
• Actively managing all quality-relevant processes for finished medicinal products distributed by HELM SWISS in Europe, the Rest of the World, and the USA is a key responsibility in this position.
• You will play a crucial role in supporting the Responsible Person/FvP in the batch release process of FDF for human use.
• Assume the responsibilities of the Responsible Person/FvP as a deputy, ensuring a seamless and effective continuation of critical tasks.
• Your duty includes ensuring compliance with GMP and GDP regulatory and legal requirements, which involves conducting training sessions for employees.
• Engage in effective communication with customers, manufacturers, and internal stakeholders on various quality-related topics.
• Provide valuable support to the QA team in inspecting third parties and subcontractors, contributing to the overall quality assurance efforts.
• Take charge of the preparation, management, and follow-up of customer and authority inspections to maintain regulatory compliance.
• Play a pivotal role in supporting product launch activities, ensuring a smooth transition and adherence to quality standards.
• Your involvement in international project teams will contribute to the success and alignment of global quality initiatives.

Your profile:

• Possessing a degree in pharmaceutical or natural science studies is a fundamental requirement for this role.
• In addition to your academic background, you bring several years of hands-on experience in Quality Assurance, ideally with prior experience as a Responsible Person in the pharmaceutical industry.
• Your enthusiasm for collaborating in an international team aligns seamlessly with the collaborative nature of this position.
• Excellent communication skills are a key attribute we are looking for in a candidate to effectively interact with diverse stakeholders.
• The role requires a proven track record and references attesting to your successful contributions in similar capacities.
• Fluency in English is a mandatory requirement, with an additional benefit if you have a B2 level proficiency in German.
• Familiarity with European and US guidelines in the pharmaceutical industry is highly valued and considered advantageous for this role.