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GCP Associate Director/ Director, R&D Quality

Employer
Orchard Therapeutics
Location
UK
Salary
Competitive
Closing date
28 Jan 2022

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Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
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DescriptionFull-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 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).
RequirementsRequirements
  • 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).
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