Associate Director/ Director, Corporate Quality Assurance

Associate Director/ Director, Corporate Quality Assurance

Location: Boston, MA (London, UK)

Reporting to: Senior Director, R&D and Corporate Quality Assurance

Orchard Therapeutics is a leading global fully integrated commercial-stage company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies. Orchard’s portfolio of autologous ex vivo gene therapy programs has demonstrated sustained clinical benefit in over 150 patients across five disease areas.

These programs include Strimvelis®, the first autologous ex vivo gene therapy approved by the EMA in 2016, 3 programs in advanced registrational studies in MLD (metachromatic leukodystrophy), WAS (Wiskott Aldrich syndrome) and ADA-SCID (adenosine deaminase severe combined immunodeficiency), 2 other clinical programs in X-CGD (X-linked chronic granulomatous disease) and beta-thalassemia, as well as an extensive preclinical pipeline.

Job summary

Being responsible for the management and oversight of the Orchard Quality Management System (QMS) and EDMS and to ensure compliance with applicable US and EU Good x Practice (GxP) standards and requirements.

Key Elements and Responsibilities

• Management and oversight of the Orchard Quality and Document Management Systems.
• Manage staff to administer and execute such quality programs as:
• Deviation System
• Change Control
• CAPA Management
• Complaint Management
• Compliance Training
• Internal/External audits
• Key Performance Indicator Reporting for Management Review
• Vendor Management
• Strategize Quality Systems team goals in alignment with the company and Quality Organization’s vision
• Foster a Quality culture of proactive thinkers and partnership to ensure right the first time.
• Drive continuous improvement through the monitoring of metrics
• Partner cross functional stakeholders to finalize implementation of the EQMS (Master Control).
• Supports internal partners to ensure trouble free pre-approval and Regulatory inspections and interactions, as required.
• Participate in, support and represent the Quality Management System in internal management reviews as well as in regulatory and third-party inspections at Orchard.

Skills & Abilities

• Expertise in compliance with respect to pharmaceutical/biologics Quality Systems and Quality Risk management
• Skilled in problem solving, root cause analysis, decision-making, and corrective action management
• Strong interpersonal skills and the ability to work well as part of a team
• Solid organizational and time management skills
• Excellent written and verbal communication skills

Education

Advanced degree preferred, e.g. MS or PhD in chemistry, cell biology, pharmacology, pharmacy or closely related field