At a Glance
- Tasks: Oversee supplier quality across EMEA, ensuring compliance and product excellence.
- Company: Join CSL Seqirus, a leading global influenza vaccine provider.
- Benefits: Enjoy competitive pay, health perks, and a focus on well-being.
- Other info: Be part of a diverse team that values inclusion and innovation.
- Why this job: Make a real impact in healthcare by ensuring quality and safety.
- Qualifications: Bachelor's degree and 3 years in a GxP-regulated environment required.
The predicted salary is between 45000 - 55000 £ per year.
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.
- 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.
Sr. Specialist, Supplier Quality Management (EMEA) in Liverpool employer: Seqirus Vaccines Limited
CSL Seqirus is an exceptional employer, offering a dynamic work environment where innovation and inclusion are at the forefront. With a commitment to employee growth and development, team leaders have access to comprehensive benefits and opportunities to lead impactful projects in a state-of-the-art facility dedicated to global health. Located in a vibrant community, CSL Seqirus fosters a culture of curiosity and empathy, making it a rewarding place for those looking to make a difference in the world of healthcare.
