Senior Manager, R&D Quality (Early-Stage Clinical Development) - QA10


Full-time

London, England, United Kingdom

Quality Assurance

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 early-stage clinical development 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.

Responsibilities

  • 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).

Requirements

  • BA or BS and 8+ years of relevant experience (6+ years of relevant experience with an MS).
  • Substantial previous work 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

PROFILE

  • 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