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Gyroscope

GCP QA Manager

Regulatory – London, London, City of
Department Regulatory
Employment Type Full-Time
Minimum Experience Experienced

Gyroscope: Vision for Life

Gyroscope Therapeutics is building something special – a company to preserve people’s sight and fight the devastating impact of blindness around the world. And if we are successful, our gene therapies and surgical devices will offer people the chance to see what they otherwise would have missed.

To be successful we need the right people. People who have passion for helping patients. People who can work as one toward a common goal, have fun and together bring forward the best ideas. People who celebrate success and embrace failure as an opportunity to learn and grow. If you are one of these people, we would love to meet you.

GCP QA Manager

 The position of GCP QA Manager is a quality assurance role that will provide Good Clinical Practice support to Gyroscope’s clinical-stage programmes through the development, implementation, and execution of global clinical quality systems and processes. This position will require about 20% global travel The position will report into the Head of QA.

What we expect the GCP QA Manager to do:

  • Provide support, guidance, and oversight for clinical studies with focus on compliance with Good Clinical Practice (GCP)’s regulations and guidances.
  • Provide expert Good Clinical Practice (GCP) advice and work closely with functional groups to address compliance and quality assurance trends across Gyroscope’s clinical trials.
  • Through collaboration with related Gyroscope’s functional areas, ensure Gyroscope’s clinical trials are conducted in accordance with protocols, GCP guidelines, and applicable regulatory requirements.
  • Setting priorities for QA activities, planning and conducting audits for Drug Development, as well as at clinical sites and laboratories. Leads or co-audits vendors, internal systems, and clinical sites. Conducts investigations of GCP related issues and creates corrective action plans.
  • Having responsibility for GCP aspects of Gyroscope’s Quality Management Systems.
  • Supporting the organisation through regulatory GCP inspections and co-ordinate non-functional training. Promotes and advances quality awareness throughout the organization; coordinates and provides GCP training.
  • Reviews applicable clinical documents for accuracy and internal consistency as it applies to quality (e.g., Clinical Protocols,  Clinical Study Reports, etc)
  • Author, review and/or approve clinical SOPs
  • Manage the applicable audit schedules (clinical sites, vendors, etc). Coordinate and execute audits, generate reports and follow up CAPAs to their timely completion.

What we would like to see in your skills/experience?

  • Extensive experience in a QA function, preferably in the pharmaceutical / biotech industry with focus in clinical development and operations.
  • QA GCP experience. Minimum of 5 years’ experience in pharma / biotech in a GCP role are required
  • Excellent knowledge of Clinical Trials Regulations and guidances, including FDA, ICH, WHO, or equivalent.
  • Experience and ability to conduct and lead audits.
  • Gene therapy experience is a plus , especially in early phase trials.
  • Ability to give measured and expert advice and manage complex and sensitive QA data. Ability to present findings to a varied audience.
  • Demonstrable multitasking, project management, and execution skills. Strong writing skills with experience preparing policies, procedures, and corrective action plans
  • Excellent interpersonal skills, including communication, basic negotiation, presentation, persuasion, conflict management, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

Qualifications:

  • BA/BS in life sciences, chemistry, engineering or closely related field
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  • Location
    London, London, City of
  • Department
    Regulatory
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced
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