Senior Manager Clinical QA

Hobson Prior is seeking a Clinical Quality Assurance Specialist for a Senior Manager position. This role involves working with the Clinical Operations and Development team and other related departments to ensure that clinical trial activities are conducted in line with regulations and company policies. The successful candidate will be responsible for interpreting and providing key metrics, supporting the development of SOPs, managing clinical quality issues and assisting with inspection readiness activities.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Work with various teams to ensure clinical trial activities follow regulations and company policies.
• Interpret and provide important metrics to various teams.
• Support the development of SOPs and serve as a quality operations reviewer.
• Use risk-based methodologies for planning and executing clinical protocols.
• Manage clinical quality issues and ensure timely implementation and closure of CAPAs.
• Lead initiatives that enhance regulatory compliance and operating efficiency.
• Assist with inspection readiness and preparation activities.
• Use knowledge of GCP, clinical development, and industry best practices to provide guidance and training on compliance issues.
• Support continuous improvement activities.
• Present key issues related to clinical quality to Quality Management.

Key Skills and Requirements:

• Bachelor of Sciences Science, Nursing, or related scientific field.
• Experience in the pharmaceutical or biotechnology industry with a focus on GCP-related Quality Assurance.
• In-depth knowledge of global GCP regulations, Good Clinical Practices, ICH Guidelines.
• Advanced knowledge in conducting and reporting audits and translating findings into corrective actions plans.
• Organisational and management skills to communicate to multi-discipline project groups.
• Ability to speak, present data and defend approaches in front of audiences and inspectors.
• Ability to comprehend technical information related to equipment, processes and regulatory expectations.
• Ability to think strategically and maintain attention to detail.
• Excellent written and verbal communication skills, strong negotiation and decision-making skills, and attention to detail.

For more information, please contact Frankie Cunningham.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click Apply and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly please select 'Contact me' at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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