Senior Quality Manager

4 weeks ago

Cambridge Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full time

Working as a Senior Quality Expert/Manager - GCP, you will act as the advisor to the Clinical Development teams on all quality related GCP activities. This will be an exciting opportunity with a clinical-stage biopharmaceutical company with multiple Phase 3 assets.

Key Responsibilities:

  • To play a key role in maintaining and monitoring the GxP QMS ensuring it meets all regulatory requirements and standards, with emphasis on GCP compliance.
  • To provide support and advice to Clinical Development teams with regards to:
  • Definition of appropriate compliant procedures within GxP functions
  • Management of quality issues
  • To ensure external contracted organisations supporting GxP activities are selected and responsibilities defined and documented.
  • To monitor the performance of GxP service providers with regards to the relevant quality standards.
  • To define and manage clinical audit programme and to preform GCP audits if required.
  • Maintain agreed quality metrics and dashboards to enable clear communication to senior management of compliance performance and any risks or issues identified.
  • To maintain awareness of, and ensure compliance with, policies and procedures relating to quality standards within the Company.

Skills/Knowledge Competencies:

  • Substantial experience of successfully managing quality issues in a biotechnology or biopharmaceutical environment.
  • Proven track record in defining, implementing and maintaining Quality Management Systems for biotechnology or biopharmaceutical companies.
  • Proven track record of monitoring and influencing the quality performance of internal functions and contracted service providers, including self-inspection and external audit experience.
  • Comprehensive knowledge of GCP requirements as applied to biologics and related industry/regulatory guidelines governing clinical trials in the EU & USA.
  • Basic understanding of GLP and GMP requirements for biologics
  • Basic Knowledge of GLP and cGMP and related industry/regulatory guidelines governing the manufacture of biologics in the UK, EU & US.
  • Ability to work in a flexible, collaborative style with colleagues and teams within the company and with external entities including CROs and consultants.

Experience:

  • Minimum 5+ years in a similar role

Salary and benefits:

A highly competitive salary, stock options, annual bonus and wider benefits package is on offer.

  • Senior Quality Manager

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job Description Working as a Senior Quality Expert/Manager - GCP, you will act as the advisor to the Clinical Development teams on all quality related GCP activities. This will be an exciting opportunity with a clinical-stage biopharmaceutical company with multiple Phase 3 assets. Key Responsibilities: To play a key role in maintaining and monitoring the...

  • Senior Quality Systems Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Cellular Highways Full time

    Job Description At Cellular Highways, we are on a mission to improve cell sorting based on new technology, make it accessible to every laboratory as well as enable new clinical applications. Our first product is an automated high-throughput sterile cell sorter for cell therapies. To support us with this mission, we need to find a Quality Manager to the join...

  • Senior Quality Systems Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Cellular Highways Full time

    At Cellular Highways, we are on a mission to improve cell sorting based on new technology, make it accessible to every laboratory as well as enable new clinical applications. Our first product is an automated high-throughput sterile cell sorter for cell therapies. To support us with this mission, we need to find a Quality Manager to the join the team. As a...

  • Senior Quality Systems Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Cellular Highways Full time

    At Cellular Highways, we are on a mission to improve cell sorting based on new technology, make it accessible to every laboratory as well as enable new clinical applications. Our first product is an automated high-throughput sterile cell sorter for cell therapies. To support us with this mission, we need to find a Quality Manager to the join the team. As a...

  • Senior Director

    3 days ago

    Cambridge, Cambridgeshire, United Kingdom AL Solutions Full time

    George Higginson is currently searching for an experienced Director of Quality Assurance in GCP. In this position, you will support senior management in ensuring Quality is at the heart of all company initiatives and act as advisor to the Clinical Development teams on all quality related GCP activities. To play a key role in defining, maintaining and...

  • Senior Director

    3 days ago

    Cambridge, Cambridgeshire, United Kingdom AL Solutions Full time

    George Higginson is currently searching for an experienced Director of Quality Assurance in GCP. In this position, you will support senior management in ensuring Quality is at the heart of all company initiatives and act as advisor to the Clinical Development teams on all quality related GCP activities. To play a key role in defining, maintaining and...

  • Senior Quality Assurance Officer

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom CK Group- Science, Clinical and Technical Full time

    We are currently seeking a highly experienced and dedicated Senior Quality Assurance Officer to join our Quality Assurance team. Company Information: Our client is a growing Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the...

  • Senior Quality Assurance Officer

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom CK Group- Science, Clinical and Technical Full time

    We are currently seeking a highly experienced and dedicated Senior Quality Assurance Officer to join our Quality Assurance team. Company Information: Our client is a growing Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the...

  • Senior Quality Assurance Officer

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom CK Group- Science, Clinical and Technical Full time

    We are currently seeking a highly experienced and dedicated Senior Quality Assurance Officer to join our Quality Assurance team. Our client is a growing Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the development of complex,...

  • Senior Quality Assurance Officer

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom CK Group- Science, Clinical and Technical Full time

    We are currently seeking a highly experienced and dedicated Senior Quality Assurance Officer to join our Quality Assurance team. Our client is a growing Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the development of complex,...

  • Senior Quality Expert

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    Job Purpose As a Senior Quality Expert (Good Clinical Practices/GCP), you will support senior management in ensuring Quality is at the heart of all company initiatives and, specifically, you will act as advisor to the Clinical Development teams on all quality related GCP activities. Key accountabilities: To play a key role in maintaining and monitoring...

  • Senior Quality Assurance Officer

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom CK Group- Science, Clinical and Technical Full time

    We are currently seeking a highly experienced and dedicated Senior Quality Assurance Officer to join our Quality Assurance team. Company Information: Our client is a growing Contract Development and ManufacturingOrganisation(CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the...

  • Senior Quality Assurance Officer

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom CK Group- Science, Clinical and Technical Full time

    We are currently seeking a highly experienced and dedicated Senior Quality Assurance Officer to join our Quality Assurance team. Company Information: Our client is a growing Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the...

  • Senior Quality Assurance Officer

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom CK Group- Science, Clinical and Technical Full time

    We are currently seeking a highly experienced and dedicated Senior Quality Assurance Officer to join our Quality Assurance team. Company Information: Our client is a growing Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the...

  • Senior Quality Systems Manager

    3 days ago

    Cambridge, Cambridgeshire, United Kingdom Pure Resourcing Limited Full time

    Lead on projects to improve the QMS Manage the multi-site technical specifications, international quality standards and customer quality requirements review and implementation process. Oversee the global quality systems including all global quality procedures/policies The Global QMS Manager will support strategic initiatives with the SLT and work...

  • Senior Quality Assurance Officer

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom CK Group- Science, Clinical and Technical Full time

    We are currently seeking a highly experienced and dedicated Senior Quality Assurance Officer to join our Quality Assurance team. Our client is a growing Contract Development and ManufacturingOrganisation(CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the development ofcomplex,...

  • Senior Engineer, Software Quality

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    Senior Embedded Engineer - Biotech Software Newton Colmore is working with an innovator of scientific instrumentation in Cambridge, and we are looking to find a senior embedded software engineer to join their team. You will be utilising your embedded software skills to develop novel solutions for highly complex lab instruments This will include complete...

  • Senior Engineer, Quality

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Full time

    Senior Embedded Engineer - Biotech Software Newton Colmore is working with an innovator of scientific instrumentation in Cambridge, and we are looking to find a senior embedded software engineer to join their team. You will be utilising your embedded software skills to develop novel solutions for highly complex lab instruments This will include...

  • Senior Specialist, Quality Management

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Senior Specialist, Quality Management - Patient Safety page is loaded Senior Specialist, Quality Management - Patient Safety Apply locations United Kingdom - Cambridge time type Full time posted on Posted 7 Days Ago job requisition id R0040912 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. ...

  • Quality System Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Cellular Highways Full time

    Job Description At Cellular Highways, we are on a mission to improve cell sorting based on new technology, make it accessible to every laboratory as well as enable new clinical applications. Our first product is an automated high-throughput sterile cell sorter for cell therapies. To support us with this mission, we need to find a Quality Manager to the...