QA Director
- Permanent
- Quality Assurance, Quality Systems
This vacancy has now expired. Please see similar roles below...
Hobson Prior are looking for a QA Director to join a clinical-stage gene therapy company on a permanent basis in New York. The purpose of this role is to ensure that the organisation's Quality Strategy and Quality Management System related to Clinical operations is implemented, inspection ready and maintained in a state of control in compliance with applicable national and international GxP rules and regulations.
Job Responsibilities:
- Accountability for the QMS System, ensuring that it's fully deployed, up to date and maintained in a state of compliance.
- Promote a "Quality Mindset" with peers and stakeholders by providing proactive thinking and strong input and guidance to situations that arise that require in-depth knowledge of GCP regulations and the organisation's QMS.
- Provide CQA oversight and support to Pre-Clinical and Clinical Operations conducted via the US team.
- Provide CQA oversight and follow up on 3rd party vendor and suppliers (CRO's, CMO's, etc.) performance.
- Represent as the QA representative in project meetings providing input and guidance to ensure compliance throughout the project lifecycle.
- Represent as the QA lead on all clinical quality matters relating but not limited to regulatory submissions, clinical protocols and the conduct and reporting of clinical trials.
- Contribute to the selection of and ongoing auditing of key suppliers, vendors, CROs and CMOs.
- Support and/or execution of audits e.g: Site, vendor, process, systems, regulatory submission, clinical trial documents.
- Manage the Clinical Review Board in response to any identified serious complaints and/or quality incidents to assure all products meet safety and quality requirements, and the safety of subjects and patients is protected. When safety or quality issues are identified with products, assure processes are implemented to protect the safety of objects and patients.
- Prepare for, and host, successful regulatory inspections for GCP requirements.
- Ensure any findings reported in such inspections are appropriately remediated in a timely manner.
Key Skills:
- Strong interpersonal skills must have the ability to establish and maintain effective working relationships with internal and external peers and stakeholders.
Requirements:
- Science based degree e.g. BSc or MSc.
- Minimum 10 years' experience working at senior management level in a pharmaceutical/biopharmaceutical Quality Assurance commercial and GCP function preferably sterile products.
- Extensive knowledge, and hands on understanding and application of GCP and GMP regulations and substantial experience with defining and harmonising Quality Management Systems combined with a proven track record of having successfully implemented these.
- Experience with hosting and follow up on corporate audits, client audits and regulatory inspections.
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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