Clinical Quality Assurance Manager (home-based)
Hobson Prior are working with a world-wide biopharmaceutical company who are determined to change the lives of patients living with serious and rare diseases. Our client is looking for a Clinical Quality Assurance Manager to join them on a permanent basis.
- Full understanding of and practical experience establishing and fostering compliance with ICH E-6 Guideline for Good Clinical Practice.
- Accountable for quality assurance program in supporting GCP activities; this includes overseeing and assisting with training and auditing programs, development and review of SOPs, as well as conducting vendor and site audits.
- Establish and maintain a risk-based and scientific-based quality system to support Good Clinical Practice.
- Represent the organisation during regulatory agencies and vendor audits.
- Utilizes a quality system approach to ensure all GCP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellence.
- Prepare, review and approve external and internal reports and other documentation required by regulatory agencies, or customers, to support the quality assurance function. Provide support and training to other staff members to develop additional auditing resources.
- Contribute to operational excellence initiatives, both in the department and companywide, which result in the overall improvement in both areas.
- Co-operate with colleagues in Clinical, Regulatory, and Medical departments to increase the overall effectiveness of the Quality role, and instil a Quality Improvement approach in all activities.
- Audit and prepare audit reports on the facilities of vendors, Investigator Sites and outside contract organizations.
- Strong communication skills (verbal and written), and presentation skills.
- Ability to work independently and manage variable workloads.
- Highly organised with a strong attention to detail, clarity, accuracy and conciseness.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Minimum BS degree in Chemistry, Life Science or related discipline.
- A minimum of 7 years QA experience in regulated industry such as pharmaceutical, biologics or device; an advanced degree and a minimum seven (7) years of equivalent experience preferred.
- Full understanding of ICH/FDA GCP guidelines, with a working knowledge of cGMP and GLP is essential.
- Broad knowledge of risk-based quality systems approaches consistent with ICH E-6 for Good Clinical Practice.
- Understand device regulations, development processes and FDA / EMA inspection procedures is also required.
- Knowledge of clinical development process and Phase I-IV trial operations and the related regulations/guidelines.
- Experience with Phase I thru IV, particularly Phase III; experience with Regulatory approval, NDAs and MAAs.
- Experience with effectively managing FDA / EMA inspections, working with regulators and customer audits.
- Experience developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs.
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.
$175000 - $200000 per annum
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