Site QA Head CSL Seqirus Amsterdam, EU Qualified Person & RP

Position Summary

Reporting into the Global Head of Batch Release, the Quality Assurance & Site Quality Head will provide strong leadership and strategic direction to the site quality organisation.

The individual is accountable to build and maintain a strong quality culture within their home facility and throughout the Seqirus Network. This position will manage, direct and maintain the company’s quality programs to ensure regulatory compliance of all GMP functions at the site.

This individual has the ultimate accountability for Quality at a given site and will be the key Quality contact, and license holder where applicable, for external regulatory agencies during inspections and inquiries. This individual is the primary Quality Partner to the Site head and will serve as a key member of the Site Leadership Team representing all quality functions based at the facility.

The incumbent will have demonstrated strong technical knowledge, cGMP compliance and business acumen. This individual must have demonstrated capabilities in execution of risk-based and compliant decision making, quality programs and systems and company infrastructure.

This position will be based in Seqirus Netherlands B.V.. The role requires the ability to build and maintain strong relationships and collaborate effectively with all levels and cross functionally within the organisation.

As senior QP, the role will also involve execution of the duties of a Qualified Person in line with the EU requirements and that appropriate quality standards and systems are in place and applied across the Amsterdam testing and release facility in accordance with regulatory and Seqirus global requirements.

As senior RP, the role will also involve execution of the duties of a Responsible Person for Seqirus Netherlands B.V. in line with the EU requirements.

Responsibilities include:-

• Lead the Site Quality Leadership team to develop cross functional working, foster collaboration and develop the Site-based Quality community.
• Manage and cascade a Site wide Quality plan that captures the goals and tactics. Ensure that the cross functional Quality governance and project forums are sponsored and supported appropriately, delivering outputs as required.
• Be the primary point of contact for Quality as it relates to regulatory inquiries or inspections. Ensure that an effective Quality Assurance function is established in the testing and release laboratory in Seqirus Netherlands BV and that quality systems are developed and maintained to ensure compliance with regulatory requirements, Seqirus standards & best practice.
• Ensure Site Master File, Company Master File and Quality Agreements with the manufacturing site Quality functions and R&D QA are maintained.
• Collaborate with internal and external partners to enable compliant and successful manufacturing (e.g. technology transfers, validation, testing, release, and lifecycle management), ensuring all program and corporate goals are met.
• Partner with all functions to proactively identify and mitigate Quality issues/concerns
• Ensure adherence to deviation management and change control procedures/policies
• Collaborate with business partners including quality leaders, site leadership, supply chain leadership and others to identify improvement opportunities across the organisation.
• Lead efforts to automate processes and procedures to reduce errors and improve product quality.
• Work with operations leaders and team members to define the implementation strategies for continuous improvement across the organisation.
• Develop appropriate tools and methods to sustain improvements across the organisation.
• Lead proactive risk assessments to identify and mitigate quality issues
• Ensure appropriate CAPA implementation and management to prevent recurrence
• Share best practice and drive knowledge sharing
• Represent Seqirus during GMP audits and inspections
• Ensure inspection readiness across the manufacturing network
• Support the development and implementation of global processes and procedures consistent with regulatory
• requirements and corporate standards.
• Accountable for quality oversight at the site ensuring compliance with EU regulations.

Qualifications, Skills and Experience: _

• A degree or equivalent in a life science meeting the eligibility requirements for EU Qualified Person.
• Must have experience of working in a management/leadership QA role for a minimum of 2 years. Minimum of 5 years’ experience in cGMP role, with Vaccines, Steriles and Biological products experience preferable.
• Experience of Quality Assurance techniques and industry practice
• Leadership skills in supervision of teams
• Fluency in English
• Substantial industry experience: vaccines, Steriles and biological experience is preferable.
• Demonstrated ability to influence at all Organisational levels through clear, concise and impactful verbal and written communication skills
• A track record in cementing teams and delivering outstanding effectiveness from those teams.
• The ability to deal with complexity and uncertainty and to remain calm under pressure.
• Effective presentation and meeting skills within all levels of the organisation and with external colleagues and collaborators
• In depth knowledge of cGMP, specifically EU legislation.

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join 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.

We want Seqirus to reflect the world around us

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. Learn more Inclusion and Belonging | CSL.

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