You manage compliance and quality assurance for external partners, ensuring effective data management and collaboration on regulatory issues while driving continuous improvement initiatives.
Anforderungen
- •Master’s degree in Life Sciences or equivalent experience
- •Minimum 3–5 years in pharmaceutical or medical device
- •Experience in Parenteral Sterility Assurance is a strong plus
- •Technical understanding of sterility assurance
- •Up to date with technological and regulatory developments
- •Excellent communication and negotiation skills
- •Strong detail-oriented and organizational skills
- •Collaborative team player with proactive mindset
- •Fluency in English is required
- •Experience with Licensing or External Manufacturing Partners
- •Familiarity with stability study management
- •Prior involvement in regulatory inspections
- •Understanding of KPI systems and performance monitoring tools
Deine Aufgaben
- •Manage compliance with GMP guidelines and product registration.
- •Provide quality oversight of GMP data and KPIs.
- •Ensure effective knowledge management of partner-manufactured products.
- •Collaborate on regulatory submissions and Health Authority inquiries.
- •Contribute to continuous improvement initiatives in QA.
- •Collect and analyze manufacturing data from partners.
- •Act as QA representative on project teams with partners.
- •Coordinate changes, deviations, and CAPAs with cross-functional teams.
- •Support KPI tracking and reporting for partner performance.
Original Beschreibung
# QA management of Licence and partner
**EMEA, CH, Kanton St. Gallen, St. Gallen, CSL Vifor** | **Full time**
# QA Management – Licensing & External Partner
In this role, you will be responsible for ensuring that our licensed and partner-manufactured products meet the highest GMP and regulatory standards.
**Your Responsibilities**
* Manage Licensing/External Partner activities to ensure compliance with GMP guidelines, product registration requirements, and internal SOPs (e.g., MBRs, validation plans/reports, deviations, complaints, change controls).
* Provide quality oversight of GMP data and key performance indicators (KPIs) related to Licensing/External Partners.
* Ensure efficient knowledge management of products manufactured by Licensing/External Partners.
* Collaborate with Regulatory Affairs (CMC) team on regulatory submissions and responses to Health Authority inquiries.
* Actively contribute to continuous improvement initiatives within the QA department.
**Functional Responsibilities**
* Collect, organize, and analyze manufacturing and control data provided by Licensing/External Partners for products under CSL Vifor responsibility.
* Serve as the QA representative and active member of project teams involving Licensing/External Partners.
* Coordinate and manage processes such as changes, deviations, OOX investigations, and CAPAs in collaboration with cross-functional teams (Supply Chain, Regulatory Affairs, Pharmaceutical Development, Qualified Person).
* Support KPI management, tracking, and reporting to evaluate Licensing/External Partner performance.
**Your Qualifications**
* Master’s degree in Life Sciences or a related field, or equivalent professional experience in the pharmaceutical industry.
* Minimum of 3–5 years of experience in the pharmaceutical or medical device environment, ideally in Quality Assurance and/or Manufacturing.
* Experience in Parenteral Sterility Assurance or Environmental Monitoring is a strong plus.
* Technical understanding of sterility assurance from both scientific and compliance perspectives.
* Up to date with technological and regulatory developments in the parenteral manufacturing sector (e.g. aseptic filling, Annex 1).
* Excellent communication and negotiation skills with external stakeholders and contract manufacturing organizations.
* Strong detail-oriented, planning and organizational skills.
* A collaborative team player with a solution-oriented and proactive mindset.
* Fluency in English is required; other language skills are advantageous.
**Preferred Requirements:**
* Experience in working with Licensing or External Manufacturing Partners.
* Familiarity with stability study management.
* Prior involvement in regulatory inspections and health authority interactions.
* Understanding of KPI systems and performance monitoring tools.
We are looking for a solution-oriented, proactive individual who enjoys continuous improvement and is eager to contribute meaningfully to our QA organization.
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