Associate Director, Quality Assurance Support
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Job Location:
Bern - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
CSL Behring is a global biotherapeutics leader driven by its promise to save Bern more than 1500 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.
For our location in Bern we are currently looking for a
Associate Director Quality Assurance Support
Responsibilities
Responsible for routine and non-routine quality oversight activities in collaboration with local operational units (Maintenance & Utilities Quality Control warehouse & internal transport) and qualification activities in Opex and periodic re-qualification projects
Ensures operational quality management according to cGMP to guarantee appropriate service quality for Value Streams and compliance with CSL standards and procedures
Reviews and approves complex GxP records and documentation
Supports and approves complex quality risk assessments non-conformances investigations CAPAs and change controls
Monitors relevant quality performance metrics and drives improvement initiatives
Leads project management and implementation of complex cross-functional and global projects
Acts as Subject Matter Expert (SME) for complex deviations and changes during inspections and audits; collaborates with global QA Support Functions
Quality Oversight & Stakeholder Collaboration
Ensures proactive QA oversight and drives quality decisions with stakeholders across maintenance/utilities utility monitoring material management warehousing and QC
Conducts periodic warehouse floor tours with warehouse supervision and Supply Chain teams to address improvements exceptions and material usage decisions
Initiates and supports implementation of new Quality on the Floor activities
Deviation Change & Document Handling
Independently manages complex and cross-functional deviations at local and cross-site level
Performs Quality Delegate function for change management
Reviews and provides QA approval for GxP documentation within assigned areas
Additional Responsibilities
Reviews and completes APR/PQR raw material data
Leads cross-functional Tier 1 meetings (QC warehouse M2U)
Coordinates and delivers GMP training and qualification of new employees in QA Support Functions
Independently prepares and presents quality investigations and changes to health authorities
Qualification
- 8 years of experience in a similar role with a high degree of independence and strong self-directed learning capabilities
- cGMP and Compliance
- Engineering & maintenance operations
- Utility monitoring programs
- Material management warehousing & logistics
- Quality control & analytical methods
- Change control management
- Deviation management
- CAPA management
- Strong collaboration skills with proven ability to build cross-functional networks and drive efficient interfaces between departments
- Coaching & mentoring skills with the ability to upskill colleagues in areas of expertise
- Excellent communication abilities capable of explaining complex technical matters in a clear concise and precise manner
- Strong influencing and presentation skills enabling effective stakeholder engagement and decision-making
We are looking forward to receiving your online application. Applications must include a motivation letter and CV as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being CSL.
You Belong at CSL
At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit Experience:
Director
Key Skills
- Quality Assurance
- FDA Regulations
- ISO 9001
- Root cause Analysis
- Biotechnology
- Clinical Trials
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- cGMP
- HACCP
About Company
Join the thousands of people who safely donate plasma each week at CSL Plasma and get rewarded for your time.
