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 a few years ago, it is in an exciting phase where a Quality Assurance (QA) 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 GCP teams.
We are seeking a candidate with outstanding Good Clinical Practice (GCP) knowledge, excellent audit skills of investigator sites, vendors and internal processes including Inspection readiness activities , communication, and facilitation skills, and the ability to manage multiple projects. Responsibilities
- Be the reference QA GCP person.
- Manage the GCP related day to day activities of the QA department.
- Providing day-to-day GCP advice and support to the Clinical trials teams. Working closely with clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement.
- Manages multiple GCP projects and ensures overall and timely completion of tasks.
- Leads the development of risk-based annual audit strategies for GCP.
- Leads and manage all GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors.
- Escalate signals identified to risk of business continuity due to any GCP quality issue.
- Trains and manages contracts auditors.
- Leads in readiness preparation, and directly support regulatory agency inspections.
- Lead and manage the coordination of the 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).
- Bachelor's Degree required,- Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred.
- 10+ years GCP QA compliance experience, including extensive hands-on execution of GCP audits (internal, vendor and Investigator site audits).
- 6+ years GCP regulatory inspection management experience and demonstrated management of audit teams.
- 3+ years of people management experience.
- Expert in GCP regulations and a recognized expert resource on a range of clinical compliance topics.
- Good understanding of the regulations of Advanced Therapy Medicinal Products (ATMPs) in the EU and Regenerative Medicine Advanced Therapies (RMATs) in the US is a plus.
- Expertise in compliance with respect to pharmaceutical/biologics Quality Risk management and analytics.
- Excellent written and verbal communication skills.
- Strong interpersonal skills and the ability to work well as part of a team.
- Proficient in Microsoft Office suite.
- Excellent organization skills and project management.
- A resilient and visionary Quality Professional willing to pave a path.
- Willingness/availability to travel up to 25-30% (including international travel).