(Senior) Manager Quality Assurance (m/f/x) | Munich | Pharma
In this role, you will be mainly responsible for the representation of the client in front of the health authorities in relation to the quality measures associated with its pharmaceutical licenses and its maintenance. You act as a subject matter expert for pharmaceutical law, maintain the quality awareness in the organization and closely follow developments in pharmaceutical legislation and provision for the organization.
What will your tasks as "(Senior) Manager Quality Assurance (m/f/x)" be?
- Responsible for ensuring the validity of the companies "Wholesale License".
- Maintain the quality management system in accordance with the relevant GDP principles for the defined tasks and duties of the company as set out in the current GDP guidance documents in accordance with the relevant EU directives, EU-GDP relevant directives and additional GDP requirements.
- Participation and maintenance of the EMEA quality management system
- Preparation and maintenance of the quality manual
- Self-inspections in all QM-relevant functional areas
- Appropriate education and training programs for the employees of the GDP- and QMS-relevant functional departments according to their functions described in the individual job description.
- Preparation and coordination of authority audits/customer audits
- Coordination and immediate implementation of recall actions for the products
- Management of product quality complaints
- Processing of EMEA returns
- Implementation and maintenance of relevant quality agreements
- Contribute to the global nutritional products quality policy to confirm that regulatory changes have been implemented, necessary gaps have been closed and management of food manufacturing and control has been improved
- Follow and act in accordance with the GDP guidelines (mandatory for all employees).
Your requirements as "(Senior) Manager Quality Assurance (m/f/x)"?
- University degree in a life-sciences field
- Several years of experience in the pharmaceutical industry with a focus on Quality Management / QA
- In depth knowledge of manufacturing of medicinal products
- Broad understanding of the drug development process and regulatory environment and experience with implementing QMS and processes in a regulatory environment
- Good knowledge of GMP, GDP and other relevant quality systems
- Experience in a MATRIX organization would be a plus
- Business fluency in German and English (oral and written)
Information about our client:
Our client was founded over 150 years ago and has developed into one of the leading companies in the area of human eye health. Currently there are working more than 3000 employees in more than 60 countries. The company is active in Research & Development and the production and marketing of related pharmaceuticals and medical devices.
- CV to my email: email@example.com
- Call with a presentation of the company
- I am your contact person for the entire application process (interviews to contract negotiations) i.e. You don't have to apply yourself
- Discuss other exclusive positions that are tailored to your profile
My contact details:
- Email: firstname.lastname@example.org
- Tel: 0049 (0) 89/210 93938 (direct dial)
I look forward to your application!