Senior Director, R&D Quality - P19-6
London, England, United Kingdom
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 VP Global Quality Assurance and GxP Compliance and will be a key asset in the development of and management of the Quality System of the company and the compliance and filing for exciting ex-vivo Gene Therapy Products. This opportunity is unique due to the size of the team and the ground-breaking science.
- Sets the strategy and execution for all aspects of audits and inspections across Research and Development (e.g. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GPV), Good Laboratory Practice (GLP)) for the R&D portfolio of products, processes and vendors using a risk-based approach.
- Drives and enables proactive inspection readiness for GCP, GPV and GLP.
- Determines collaborative relationships with quality vendors for inspection and audit support as appropriate, driving oversight.
- Collaborates with other organization-wide inspection and audit functions to enable coverage of GCP, GPV, GLP activities across R&D functions
- Benchmarks through industry consortia and industry networking to assure up to date and relevant information be utilized in the oversight of R&D Quality and the conduct of audits and inspection planning.
- Leverages the data in the R&D Quality Management System (QMS) to monitor Key Performance Indicators and areas of risk.
- Determines and manages workload and resources for the audits and inspection team.
- Engages in inspection readiness and inspection management activities as well as the development of associated processes to enable R&D to be in a steady state of inspection readiness.
- Approves the overall R&D audit strategy and R&D annual Master Audit Plan (GCP, GPV, GLP).
- Engages senior leadership across R&D to understand risks, enable awareness and highlight audit results.
- Establishes the overall R&D inspection strategy and assures inspection planning across R&D function as well as enables ongoing efforts to maintain a steady state of inspection readiness. Engages senior leadership to enable execution of the plan
- Provides leadership & Management for the audit and inspection organization, cascading messages and goals from senior management, managing & prioritizing team workload, managing team performance
- Assures positive relationship with inspectors before, during and after Orchard regulatory inspections. Informed of clinical site and key vendor inspections activities & outcomes and may coordinate/provide input to inspection responses impacting the organization
- Assures coordination efforts for responding to inspection related findings, communications, and actions and providing oversight of execution against subsequent inspection action plans
- Leads integration of audit data and planning across R&D, in collaboration with non-R&D Quality audit teams to ensure consistency across the organization
- Identifies, approves and serves as the process owner / provides oversight of the design and implementation of relevant GCP, GPV and GLP Audit and Inspection Management processes and procedures, including metrics, thresholds, continuous improvement initiatives.
- Manage the GCP, GPV and GLP related day to day activities of the Quality Assurance department
- Be the reference QA GCP and GPV person for the company
- Be responsible for all GCP, GPV and GLP quality assurance activities, SOPs, policies and training
- Prepare for, conducting, facilitating and responding to regulatory agency audits internally or at supplier sites/ preparing for and conducting internal audits / identifying needed actions as a result of internal or external audits, or internal process meetings
- Participate in establishing, maintaining and updating standards and ensuring compliance of standards with applicable regulatory requirements
- Review documentation to ensure that controlled documents are followed, standards of GCP, GPV and GLP quality are maintained, and documentation is complete
- Oversee quality assurance planning for clinical study related activities
- Perform review of Corrective and Preventive Actions (CAPAs) and recommending effective solutions to enhance quality and efficiency, establishing GCP, GPV and GLP QA processes and standards and performing compliance related training
- Ensure systems at contract research organizations (CROs) are synchronized with current regulations, company's expectations and quality standards.
- Raise early signals to risk of business continuity due to any GCP, GPV and GLP quality issues. Provide direction on mitigation measures.
- 15 years pharmaceutical or biotechnology drug development experience, 8 years GCP, GPV and/or GLP QA compliance experience.
- 10 years GCP, GPV, GLP regulatory inspection management experience and demonstrated management of an audit team
- 10 years of people management experience
- Expert in GXP regulations
- Risk Management and analytics
- Outstanding communication and presentation skills. Proven track record of leadership, accountability and willingness to confront complex problems. Very strong people management skills and ability to create quality culture.
- 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
All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.