Quality Manager Corporate Systems & Projects - HELM Pharmaceuticals (m/f/d)
HELM AG ·
- Category
- Management
As Quality Manager Corporate System & Projects (m/f/d), you will play a key role within the Global Quality Unit, contributing to the continuous optimization of HELM’s Pharmaceutical Quality System (PQS). You will act as a quality representative in international, interdisciplinary teams and support development for finished dosage forms across EU and US markets. This position combines strategic quality system responsibilities with hands‑on project support across standard generic and differentiated finished dosage forms, covering key therapeutic areas such as oncology, hematology, infectious diseases, or dermatology.
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.