External Supplier Quality Specialist - CSL Seqirus

CSL; Liverpool; On-site; GBP 55,000 - 75,000; Full time

Job summary

CSL Seqirus is seeking a Supplier Quality Management professional to oversee supplier quality activities across the EMEA region. The role focuses on qualification, risk assessment, change control, and issue resolution to ensure product quality and regulatory compliance.

Responsibilities include managing supplier qualification, reviewing quality documentation, and collaborating with cross-functional teams to resolve issues and maintain continuity of supply.

Qualifications

• Bachelor's degree in science or related field.
• Minimum 3 years' experience in a GxP-regulated environment.
• Experience in pharmaceutical, biotechnology, vaccine, medical device, or related industries.
• Knowledge of supplier quality management processes (qualification, change control, CAPA, etc.).
• Experience working in a global environment with regulatory requirements.

Responsibilities

• Manage supplier qualification, onboarding, periodic review, and ongoing oversight in line with GxP and company standards.
• Review supplier quality documentation including deviations, investigations, CAPAs, and regulatory inspection outcomes.
• Assess supplier changes, quality events, and compliance risks using a risk-based approach.
• Collaborate with suppliers and internal stakeholders to investigate and resolve quality issues.
• Establish and maintain Supplier Quality Agreements with suppliers and service providers.
• Work with Quality, Manufacturing, Regulatory Affairs, Procurement, and Supply Chain to support supplier-related activities.
• Apply quality risk management principles to support supplier oversight decisions.
• Contribute to continuous improvement within the Supplier Quality Management program.

Skills

GxP experience

Supplier quality management

Quality systems

Analytical skills

Global environment experience

Stakeholder management

Education

Bachelor's degree in Science/Engineering/Quality

Job description

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

• Bachelor's 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.
• Experience of working in a global environment.
• 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.
• The ability to self-organise.

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 of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is 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.

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.

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.