Quality Manager Corporate Systems & Projects - HELM Pharmaceuticals (m/f/d)

Your tasks:

• In this role, you support finished dosage form programs across all quality‑relevant aspects, from development through to product launch.
• A core part of the position is maintaining and further developing the global and local Pharmaceutical Quality System (PQS) in line with corporate quality objectives and regulatory requirements.
• You ensure regulatory compliance for Helm Pharmaceuticals in its role as wholesaler, importer, and releaser of medicinal products and APIs.
• In addition, you provide quality support for clinical development activities, including oversight of GCP Quality Assurance.
• The role includes reviewing, implementing, and continuously optimizing global quality procedures, with active contribution to the Quality Maturity Program.
• Acting as a quality partner, you advise project teams on quality‑related regulatory developments such as EMA, FDA, and EU‑GMP requirements.
• Ownership is taken for key quality topics including Quality Agreements, supplier qualification, PQS documentation, and the execution of GMP audits.
• Furthermore, you provide expert support and technical troubleshooting on quality‑related topics across the organization.

Your profile:

• You hold a Master’s degree in a scientific discipline, such as Pharmacy, Chemistry, Biology, or an equivalent field.
• Several years of experience in pharmaceutical Quality Management, ideally within a generics environment, form a strong foundation for this role.
• Solid knowledge of EU and US pharmaceutical regulations as well as German drug law is part of your expertise.
• Experience in audits, clinical quality management, and pharmaceutical development and manufacturing processes complements your profile.
• You are confident in working with MS Office applications and quality‑relevant IT systems such as eQMS, LIMS, or project management tools.
• Excellent English communication skills, combined with the ability to work effectively in international, cross‑functional teams, complete your profile.