HELM Pharmaceuticals GmbH is a B2B pharmaceutical company focused on identification, development, authorization, and licensing of pharmaceutical products, with selected technology, to global markets. Headquartered in Hamburg, Germany, with further offices in Europe and beyond we build solid partnerships to take an idea to market, adding value to the business of our partners by our knowledge of pharmaceutical development, regulatory and clinical affairs, manufacturing and supply chain management. For our operational activities we are looking for an experienced Operations Support Manager (m / f / d) at our offices in India.
Your tasks :
- Cross-functional collaboration with Operations Management, Procurement, and Quality Unit on maintaining operational business with Asian API suppliers and CMOs.
- Support the global Quality Team in inspections and audits of third parties and subcontractors as well as performing GMP- / GDP-audits at suppliers for Helm Pharmaceuticals GmbH primarily in India and Asia.
- Support the Quality Unit and the Operations team by jointly advancing solutions to quality related matters in your region.
- Maintaining the global Pharmaceutical Quality System of Helm Pharmaceuticals GmbH at the local site through targeted support in the established processes.
- Support of commercial evaluation and negotiations including requesting and evaluation of proposals and budget quotations.
- Support your local colleagues in Alliance Management for local business partners of HELM Pharmaceuticals based in India and Asia including API manufacturers, C(D)MOs, CROs, and service providers.
- Attendance of regional and global fairs, congresses, and networking events representing HELM Pharmaceuticals.
- Maintaining and enlarging a relevant network within the regional pharmaceutical industry with special focus on GxP-related matters.
- Accompanying colleagues during business trips and meeting within India and Asia and assisting them during travel planning.
Your profile :
You have a Master´s degree in Chemistry, Pharmacy, or another related field. In addition, an MBA qualification is also helpful.Furthermore, you bring 5-8 years of relevant experience in the GxP-environment of the Pharma industry.You are aware of the challenges of the highly regulated pharmaceutical business, you will not only mediate between cultures, but also between commercial and regulatory teams.In addition, you have strong written and verbal persuasion skills, analytical skills, auditing experience, and extensive knowledge of European and US GxP-regulations.Furthermore, you can interact effectively within a multinational and interdisciplinary environment.Strong written and oral communication skills in English.You are willing to travel.