Senior Manager, R&D Quality - QA11
London, England, United Kingdom
Location: London, England
Reporting to: Senior Director, R&D Quality
Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Created two years ago, it is in an exciting start-up phase where a Quality Assurance professional can have a real impact on the work and foundations that are being created. This role will report to the Sr Director, R&D Quality located in London, England and will be responsible for providing Quality and Compliance support to and working with Orchard’s late-stage clinical development and commercial launch planning teams. We are seeking a candidate with strong Good Clinical Practice (GCP) knowledge, audit skills, communication, and facilitation skills, and the ability to manage multiple projects.
- Serve as Clinical Compliance Lead for assigned clinical trial programs.
- Handles multiple projects and ensures overall and timely completion of tasks.
- Leads development of audit plan for assigned projects and manages audit plan execution.
- Manages and/or leads GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors.
- Trains and manages contracts auditors.
- Works closely with clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement.
- Assists in readiness preparation, and/or directly support regulatory agency inspection. Assist in coordination of response to any findings.
- Leads intra/inter-departmental teams that support operations (e.g. evaluation of a new regulation).
- Evaluate, write and/or review operating procedures (e.g. SOPs), and perform other activities in support of an integrated cross-functional quality management system (QMS).
- BA or BS and extensive relevant working experience
- Must have significant GCP audit and compliance experience. Bio-pharmaceutical sponsor experience preferred.
- Experience with audit management/CAPA management programs strongly preferred.
- Recognized as an expert resource on a range of clinical compliance topics.
- Strong verbal and written communication skills and interpersonal skills.
- Proficient in Microsoft Office suite.
- Excellent organization skills and project management.
- Able to work equally well as part of a team or independently
- Bachelor’s Degree required, Masters preferred, Doctorate optional – Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred
- Certification as a Quality Clinical Research Professional or GCP auditor is a plus
- Experience of successful Pre-License Inspections and ability to conduct audits