Digital Quality Manager

CSL; Maidenhead; Presencial; GBP 50.000 - 70.000; Jornada completa

Descripción de la vacante

CSL Seqirus is seeking a seasoned Quality Systems Specialist to support GMP-compliant quality programs and validation activities. The role focuses on maintaining SOPs, leading audits, and guiding project teams on GxP requirements for computerized systems.

You will contribute to CAPA, Change Control, and Validation efforts, ensuring timely validation and continuous improvement across the quality function in a fast-paced pharmaceutical setting.

Formación

• 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.

Responsabilidades

• 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 SOPs.
• Participates in project teams to review and approve Validation documentation according to applicable 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 audits; 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 and internal stakeholders on GxP compliance relating to computerized systems.
• Collaborates to resolve technical issues, provide quality training and communicate best practices.

Conocimientos

Quality systems

GMP

Validation

Audits

CAPA

LIMS

Computerized systems

Regulatory knowledge

Educación

Bachelor degree in Engineering or Life Sciences

Herramientas

LIMS

Document Management System

Descripción del empleo

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 Validationdocumentation 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 forcomputerized 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 Seqirus

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world, CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

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.

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus