Senior Manager - Clinical Quality Assurance

Hobson Prior are working with a pharmaceutical organisation who are focused on maximizing the benefits for patients and their families that healthcare provides for them and conducting their business to meet their diversified healthcare needs worldwide. This is an exciting opportunity to be accountable for quality oversight activities of the organisation's Clinical Trials, Systems, & CROs, for leading audits and health authority inspection management activities.

Job Responsibilities:

• Acting as CQA Lead for the organisation's clinical studies.
• Scheduling, execution, and reporting of GCP audits.
• Supporting and leading health authority inspection activities.
• Supporting and leading CQA improvement initiatives and projects.
• Representing CQA at internal, cross functional team meetings.
• Supporting the training and development of CQA colleagues.

Key Skills:

• Attention to detail and accuracy.
• Strong analytical and report writing skills.
• Ability to demonstrate diplomacy and rationale in difficult situations, acting as a representative of the CQA Department, and work collaboratively across business functions.
• Creative and analytical in approach.
• Excellent interpersonal skills with an ability to communicate professionally across different levels.
• Strong independent time management skills and the ability to manage and set shifting and competing priorities.

Requirements:

• Educated to bachelor's degree in associated functional discipline or equivalent.
• Demonstrated experience in a pharmaceutical company, preferably in a Clinical Research discipline.
• Demonstrated experience in Clinical Quality Assurance.
• Health Authority inspection management.
• SOP and training material development.
• Technical and administrative capabilities to independently carry out routine, complex and for-cause GCP audits.
• Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials.
• Excellent spoken and written English.
• Ability to Travel (approximately 25%).

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.