|Sector||Pharmaceuticals & Biotechnology|
Key accountabilities and duties:
- Manage all Quality and Compliance drug product related activities of the site covering different technologies.
- Responsible that all manufacturing processes are executed on qualified equipment and validated processes.
- Setting up/managing a team of QA managers/specialists. Provides leadership to the team with responsibility for all aspects of human resource management such as qualification, development, coaching and hiring
- Act as deputy of the Responsible Person (FvP: Fachtechnisch verantwortliche Person).
- Support the development of the overall quality strategy for site.
- Partner with Operations to ensure alignment of Manufacturing and Support Functions in executing the strategy.
- Act as SME for Quality/GMP compliance at the site.
- Trains and supervises staff and works cooperatively with leadership to achieve quality and compliance goals.
- He/she supports continuous improvements programs to establish an effective Quality Management System.
- Ensure that primary responsibilities of QA are executed in line with corporate requirements, industry best practices and current regulatory requirements (cGMPs).
- Responsible for resource planning of the assigned team members with regard to the fulfillment of all production orders.
- Implements the company culture via openness for change and new ideas, cooperative teamwork and continuous improvement even outside his/her own area of responsibility. Implements a vision as important contributor to the organizations success.
- Ensures a thorough information exchange from other management levels to his/her team and the other way around through regularly team meetings and escalation of production issues.
- Ensures and manages the respective interfaces to the Manufacturing teams, QC, Support Functions, Project- and Site Engineering.
Qualification and Skills required:
- Master degree or PhD in pharmacy, biotechnology, life science or related field.
- More than 7 years of experience in the cGMP regulated pharmaceutical industry, preferably in a quality and compliance role in aseptic filling/sterile production.
- Strong background in cGMPs is an asset.
- Strong leadership skills; very good communication skills and interaction with all kind of interfaces within the organization, customers and with health authorities (Swissmedic, FDA etc.).
- Strong team orientation.
- Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.
- Sound experience in representing Quality and Compliance in the operational manufacturing environment