QA Technical Authority, Quality Technical Services

vor 1 Monat

Luterbach, Schweiz Biogen Vollzeit

**Job Description** About This Role**

This position is providing Quality Assurance input and drives activities and projects in compliance with cGMP, regulatory requirements, Quality Management System and change control system. The main responsibility is accomplished by relevant knowledge in Bulk Drug Substance manufacturing processes and the QMS to continually improve all aspects of the Quality Management System and processes. This position will contribute to ensure quality oversight and support for New Product Introduction activities (NPI), equipment and system qualifications and site deviations. This role is expected to be cross-functional between the Luterbach QA, site organization and corporate quality functions, and will also work closely with other business groups as, but not limited to, quality systems, quality control, manufacturing science, and supply chain.

You will have close collaboration with global functions (e.g. BPOs, QSOs and other Biogen sites (such as RTP site) and business groups. As such, the position is expected to have high level knowledge in manufacturing operations, equipment use and business processes within a cGMP Biotech environment as well experiences on manufacturing execution systems (Delta V/Syncade) as well as Trackwise, LIMS, electronic documentation, Enterprise Resource Planning and Change Control

**What You'll Do**
- Support deviations/GMP investigations and other quality processes to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs). Support cross functional groups on root cause analysis and development of corresponding corrective and preventive actions.
- Contribute to the batch disposition process by ensuring that all required documents are accurately and properly completed and ready for batch disposition, including all batch related deviations.
- Support inspection readiness, regulatory requests and Partners communication and requests coordination.
- Support the review metrics for identification of negative trends and drive QMS and qualification/validation improvements.
- Act as local QMS representative (eg. CAPA, Change Control, Deviation etc.) and support the review metrics for identification of negative trends.
- Provide quality oversight of qualification activities (incl. protocols and reports) and change control process to support equipment and system qualification activities including appropriate life cycle management. Revise and approve Standard Operating Procedures, work Instructions and documentation as needed.
- Provide transversal support to QA operational teams upstream and downstream as needed during NPI or projects and/or peak periods.

**Who You Are**

You bring over 10 years of quality assurance and/or operational experience in pharmaceutical or biotech manufacturing, showcasing expertise in electronic operations, team management, and strong knowledge of GxP regulations. You have strong leadership skills, and a background in process design and improvement are essential.
**Qualifications**
- Masters in Science I Engineering in Life Science orTechnical discipline.
- Approximately 10 years or more of quality assurance and/or operation experience in pharmaceutical or biotech manufacturing environment. Prior experience with fully electronic operations and management is preferred.
- Experience in team management is an asset.
- Good experience of process design and improvement. Strong working experience with GxP regulations.
- Electronic Batch Record and elogbook management will be an asset.
- Must have a good understanding with the Quality systems and business processes associated with automation and integration o f testing and production systems.
- Demonstrated and proved ability to work autonomously
- Good oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
- Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.)
- Experience in drug substance (or API) and drug product is mandatory.
- Good experience in participating in pharmaceutical technology transfer team.
- Good experience in the qualification of facilities, utilities, equipment and processes.
- Experience in preparing and coordinating regulatory inspections.
- This position may require international travel.
- Dual Language preferred with a preference for German and English level B1.

**Additional Information**

**Why Biogen?**

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

At Biogen, we are committed to building on our culture of inclusion and belonging that refle

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