Great Location
Competitive Salary
Performance Bonuses

Manager, Quality, GCP

Vacancy Salary £Competitive
Vacancy Location Cambridge
Mergefield Title {Mergefield Value}
Mergefield Title {Mergefield Value}

This is a Permanent, Full Time vacancy that will close in {x} days (x will be populated when viewing published adverts).

Kymab, a Sanofi company, is a clinical-stage biopharmaceutical company developing a deep pipeline of novel antibody-based therapies in a broad range of indications. The Company generates its product candidates using its proprietary, integrated platforms collectively called IntelliSelect®. Kymab’s platforms have been designed to maximize the diversity of human antibodies produced in response to immunization with antigens. Selecting from a broad diversity of fully human antibodies allows for the identification of antibodies with optimal drug-like properties.

To ensure GCP related activities performed at Kymab or on its behalf at contract organisations or clinical sites are performed to appropriate standards.

Key Responsibilities:

  • Contribute to the implementation and improvement of the Quality Management System (QMS) as an enabler to delivery of Kymab’s programmes, with specific emphasis on GCP requirements.
  • As part of the Quality Team, assist in ensuring that the QMS meets all relevant regulatory requirements, with specific emphasis on GCP compliance.
  • As part of the Development Quality team, develop the QMS tools to ensure ongoing efficient support to client groups.
  • To provide support and compliance advice to Kymab Development teams to ensure the logical, risk-based, application of GCP principles, as relevant, to existing or new activities within Kymab.
  • As part of the Quality Team, to deliver training in QMS tools and aspects of GCP relevant to the Kymab Development functions.
  • To provide support and compliance advice to Kymab Development teams with regards to management of GCP quality issues.
  • To use a risk-based approach regarding the assessment of quality issues so as not to compromise or impede progress of Kymab’s programmes.
  • As part of the Quality Team, ensure QMS-related actions are communicated to client groups and progress tracked within the QMS.
  • Support Development Subject Matter Experts to ensure external contracted organisations supporting Kymab GCP activities are selected and responsibilities defined and documented according to Kymab procedures.
  • When working with GCP subcontractors, work with the Director, Quality, to ensure quality responsibilities are defined and documented appropriately.
  • With the relevant CMC Project Managers and or relevant Kymab Subject Matter expert, monitor the performance of GCP/GCLP subcontractors.
  • With the Director, Quality, ensure appropriate compliance oversight of Kymab Development groups and GCP subcontractors and clinical sites, including periodic assessment and audit as relevant.
  • To maintain awareness of, and ensure compliance with, Kymab policies and procedures relating to quality standards within the Company.
  • Assist the QMS Manager in ensuring issues and metrics are communicated effectively to Kymab management.

 

Job Requirements:

Education and Experience:

  • Educated to degree standard, A-level or equivalent.
  • Experience in oversight of or conduct of clinical trials to GCP.
  • Some auditing experience would be an advantage.

Skills and Knowledge:

  • Highly developed interpersonal skills including communication and influencing skills.
  • A good understanding of ICH E6 requirements, GCP principles and EU Regulatory requirements.

Competencies:

  • Highly organised self-motivator, able to prioritise activities, work well under pressure and meet deadlines.
  • Ability to find pragmatic solutions for quality issues in a highly agile biotech environment.
  • Ability to work flexibly, collaboratively.
  • The ability to interrogate and analyse systems to identify new ways of working.

Kymab embraces diversity and equality of opportunity and are committed to building inclusive and diverse teams representing all backgrounds. We welcome and consider applications to join from all qualified candidates, regardless of their characteristics.
 

We are a young, passionate and determined company.

We want to succeed in our aims to make a difference in healthcare and make better medicines using our unique technologies.

Our headquarters are in Cambridge, UK, on the Babraham Research Campus, an established bioscience campus, home to more than 60 companies.

Since we were founded, our team has grown to more than 180 people. It’s an invigorating environment where our teams work closely and collaboratively to help us all to achieve our aims.

You’ll find your role at Kymab exciting, interesting and stimulating, with the opportunity to interact with a diverse range of colleagues, both internally and externally.

Great Location

Competitive Salaries

Performance Bonuses

Share Plan

Healthcare Cover

Life & Income Insurance

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Published

2 hours ago

Closing

14 Days
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