External Supplier Quality Specialist

Reporting to the Manager Supplier Quality Management (EMEA) this role is responsible for the quality oversight of suppliers across the EMEA region. The successful candidate will manage supplier quality activities throughout the supplier lifecycle including qualification quality risk management change control and issue resolution. Using a risk-based approach the role supports compliance with GxP requirements company standards and regulatory expectations while working collaboratively with suppliers and cross-functional stakeholders to ensure product quality regulatory compliance and continuity of supply.

Key Responsibilities

• Manage supplier qualification onboarding periodic review and ongoing oversight activities in accordance with GxP requirements and company standards.

• Review and assess supplier quality documentation including change notifications deviations investigations CAPAs regulatory inspection outcomes and quality metrics.

• Evaluate supplier changes quality events and compliance issues using a risk-based approach to determine potential impact on product quality patient safety regulatory compliance and continuity of supply.

• Partner with suppliers and internal stakeholders to investigate and resolve supplier quality issues in a timely manner.

• Establish review and maintain Supplier Quality Agreements with suppliers and service providers.

• Collaborate with Quality Manufacturing Technical Services Regulatory Affairs Procurement Supply Chain and other business functions to support supplier-related activities.

• Apply quality risk management principles and sound scientific judgement to support quality decisions and supplier oversight activities.

• Contribute to continuous improvement initiatives within the Supplier Quality Management program.

Qualifications

• Bachelors degree in Science Engineering Quality or a related discipline.

• Minimum 3 years experience in a GxP-regulated environment.

• Experience within the pharmaceutical biotechnology vaccine medical device or related industries.

• Knowledge of supplier quality management quality systems change control deviations investigations CAPA and quality risk management.

• Understanding of applicable global regulations and GxP requirements.

• Experience reviewing supplier quality documentation and assessing quality and compliance risks.

• Strong analytical communication stakeholder management and problem-solving skills.

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

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