Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
External Manufacturing Quality Manager
Your tasks and responsibilities
- Perform the quality oversight of third party manufacturers (CMO) including Radiopharmaceutical activities and internal/external suppliers.
- Ensure that the CMO follows the Quality Agreement and all relevant regulatory requirements guaranteeing that customers receive a product of high quality and according to the approved dossiers.
- Can act as delegate of the Responsible Person (Fachtechnisch Verantwortliche Person – FvP). As such, ensure that the relevant Swiss legislation is considered for all the Quality and Compliance tasks pertaining to the position.
- Prioritizes and manages CMO related topics and action items.
- Use resources across sites and across departments to achieve strategic objectives.
- Leads teams to provide highly scientific evaluation of issues intended to mitigate business and compliance risk while maintaining product supply of products with regard to strength, purity, and potency.
- Manages QAA’s with CMOs and participates in contract negotiations, disputes, and supply agreements.
- Manages the product with regards to QA, radioprotection and radio safety requirements and their implementation.
- Represent QA in product launches.
Who are you:
- Fluent in English. Any other language knowledge is an asset
- Proficiency in IT Tools: Outlook, Microsoft Office (Word, Excel, PowerPoint)
- Minimum of 5 years of relevant experience in drug product sterile pharmaceutical manufacturing and/or advanced knowledge and experience in radiopharmaceutical subject matter areas
- Experience in oversight of contract manufacturing is needed
- Broad cGMP experience and knowledge, QA/QC and regulatory compliance (US and other international agencies)
- Excellent communication skills, good presentation and influencing skills
- Ability to work in a multicultural environment
- Able to make tough decisions under pressure and be able to adapt to changes in organization structure
- Skilled in achieving results and managing others to achieve corporate, site and departmental objectives
- Great Team Player
- Flexible concerning working hours and business travel
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Functional Area: [sap_fa_20]
Entry Level: 5