Manager, QA IT

CSL; Maidenhead; On-site; GBP 45,000 - 65,000; Full time

Job summary

CSL Behring is seeking an experienced Quality Systems Specialist in Maidenhead to support GMP-compliant quality systems across Validation, LIMS, Calibration and document management. You will contribute to CAPA, Change Control and periodic audits while guiding teams on GxP requirements for computerized systems.

Candidates should have a strong background in cGMP, FDA/EMA regulations, and a proactive approach to continuous improvement within a pharmaceutical manufacturing setting.

Qualifications

• 5+ years' quality systems experience in pharmaceutical manufacturing/cGMP environment.
• Knowledge of current Good Manufacturing Practices (cGMP).
• Knowledge of FDA and EMA requirements.

Responsibilities

• Provide support on Quality systems to ensure GMP compliance.
• Develop, maintain, and improve GMP-related quality control systems including SOPs.
• Participate in project teams to review and approve Validation documentation.
• Support quality systems related to Validation, LIMS, Calibration, Document Management, Deviation Management, CAPA, and Change Control.
• Write and manage validation plans ensuring timely validation/revalidation.
• Conduct internal audits and assist with 3rd party audits; drive continuous improvement projects.
• Support GxP health authority inspections as SME for computerized systems topics.
• Provide guidance on quality/regulatory requirements to teams on GxP compliance for computerized systems.
• Collaborate to resolve issues, provide quality training, and share best practices.

Skills

Quality systems

cGMP knowledge

FDA/EMA knowledge

Regulatory guidance

Education

Bachelor degree in engineering or related science

Job description

Responsibilities

• Under general direction, provides support on Quality systems to ensure compliance with company standards and GMP regulatory guidelines
• Develops, maintains and improves GMP-related quality control systems including standard operating procedures (SOPs)
• Participates in project teams to provide review and approval of project Validation documentation according to applicable approval matrix or procedures
• Supports quality systems related to Validation, LIMS, Calibration, Document Management, Deviation Management, CAPA, Change Control, and Enterprise Learning Management
• Writes and manages validation plans, ensuring appropriate, timely validation/revalidation is maintained
• Conducts internal audits and assists with 3rd party quality audit; plans and implements continuous improvement projects
• Supports GxP health authority inspections by serving as subject matter expert for computerized systems topics
• Provides guidance on quality and regulatory requirements to project teams, internal stakeholders and other teams on GxP compliance relating to computerized systems
• Collaborates to resolve technical issues, provide quality training and communicate best practices

Qualifications

• Bachelor degree in Engineering or a relevant scientific discipline (Chemistry, Biology, Microbiology, IT etc.) or equivalent experience
• 5+ years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environment
• Knowledge of current Good Manufacturing Practices (cGMP)
• Knowledge of FDA and EMA requirements

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

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 world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 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 https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our 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 https://www.csl.com/careers/inclusion-and-belonging

Equal 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 https://www.csl.com/accessibility-statement.