Snr Mgr Quality and Site QMR

Vantive; Liverpool; Hybrid; GBP 110,000 - 140,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Car allowance

25 days annual leave

Job summary

Vantive, a vital organ therapy company, seeks a Senior Manager, Quality and Site Quality Management Representative (QMR) for its Liverpool site. You will lead the Quality function, shape strategy and uphold compliance across GMP, ISO 13485 and regulatory requirements. You will sit on the Site Leadership Team and drive continuous improvement.

The role focuses on safeguarding product quality, maintaining regulatory compliance and developing the Quality team within a busy manufacturing site.

Qualifications

• Eight+ years of experience in Quality Assurance, Quality Control, Regulatory Affairs or related areas.
• Experience in pharmaceutical or medical device manufacturing.
• Experience with active pharmaceutical ingredient manufacturing and MHRA or FDA audits.
• Comprehensive knowledge of cGMP and EU/FDA/PIC/S requirements.
• Strong leadership, communication and project-management skills.
• Ability to take ownership and collaborate in a regulated environment.

Responsibilities

• Lead the Liverpool Quality team and sit on the Site Leadership Team.
• Represent Site Quality Management as QMR and ensure regulatory compliance.
• Ensure products manufactured and shipped meet quality and regulatory standards.
• Maintain site licenses and regulatory submission commitments.
• Oversee quality systems, qualification and validation activities.
• Drive improvements to strengthen quality, compliance and site performance.

Skills

People leadership

Project management

Communication

Problem-solving

Collaboration

Education

Scientific or engineering degree

Job description

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

We are looking for an experienced quality leader to join our Liverpool manufacturing site as Senior Manager, Quality and Site Quality Management Representative (QMR).

You will lead the site Quality function, ensuring our products, processes and quality systems meet applicable regulatory and business requirements. As a member of the Site Leadership Team, you will help shape quality strategy, support site performance and build a strong culture of compliance and continuous improvement.

Key Responsibilities

• Lead and develop the Liverpool Quality team, working through the relevant line managers.
• Act as the Site QMR and represent Quality on the Liverpool Site Leadership Team.
• Ensure products manufactured, packaged and supplied from the site comply with applicable international quality regulations.
• Maintain required site licences and ensure commitments made in regulatory submissions are fulfilled.
• Oversee effective quality systems, procedures, qualification and validation activities.
• Maintain strong GMP, ISO 13485 and regulatory performance across the site.
• Escalate significant quality matters to senior Quality leadership and, where appropriate, regulatory authorities.
• Identify and implement improvements that strengthen quality, compliance and site performance.

What You’ll Bring

• A scientific or engineering degree.
• At least eight years’ experience across Quality Assurance, Quality Control, Regulatory Affairs or a related area.
• Quality management experience within pharmaceutical or medical device manufacturing.
• Experience of active pharmaceutical ingredient manufacturing and MHRA or FDA audits.
• Comprehensive knowledge of cGMP and relevant EU, FDA and PIC/S requirements.
• Strong people leadership, communication, problem-solving and project-management skills.
• The ability to take ownership, anticipate issues and collaborate effectively in a regulated environment.

Why This Role Matters

This is a key site leadership position with responsibility for protecting product quality, maintaining regulatory compliance and developing the Quality team. You will work closely with Manufacturing and other functions to support the Liverpool site’s objectives and deliver an effective, efficient Quality System.

The role has excellent benefits including a competitive salary, annual bonus, pension contribuition, car allowance and 25 days annual leave.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link