Good Clinical Practice (GCP) Manager, R&D Quality

Location: London, England

Reporting to: GCP 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. This is an exciting 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 GCP 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 strong Good Clinical Practice (GCP) knowledge, audit skills, communication, and facilitation skills, and the ability to manage multiple projects.

Requirements

Responsibilities

• Serves as Clinical Compliance Lead for assigned clinical trial programs.
• Handles multiple projects and ensures overall and timely completion of tasks.
• Leads development of relevant audit plans for assigned projects and manages audit plan execution.
• Manages and/or leads and follows up 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, manages identified issues, and supports continuous improvement.
• Assists in inspection readiness preparation, and/or directly supports regulatory agency inspection. Assists in coordination of response to any findings.
• Supports intra/inter-departmental teams that support operations (e.g. evaluation of a new regulation).
• Evaluates, writes and/or reviews operating procedures (e.g. SOPs), and performs other activities in support of an integrated cross-functional quality management system (QMS).
• Manages the implementation, management and maintaining control of record management processes, including the Trial Master File (TMF) and associated ancillary systems to ensure compliance with regulations
• Organizes and provides TMF and associated ancillary systems process implementation and associated training and guidance to functional areas
• Ensures inspection readiness for essential documentation, materials and records for inspection by regulatory agencies, including CSRs and protocols
• Supports the Company Named Archivist where required

Requirements

• BA, BS or MS and 5+ years of relevant experience
• Substantial previous work experience.
• Must have GCP audit and compliance experience. Bio-pharmaceutical sponsor experience preferred.
• Experience with GCP 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
• Ability to travel up to 30%

Education

• Bachelor's Degree required,- Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred
• Ability to conduct internal and external GCP audits