Senior Director, Quality Management Systems - P19-15
Menlo Park, California, United States
Location: Menlo Park, CA
Reporting to: Senior Vice President, Global Quality Assurance and GxP Compliance
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 and GxP Compliance, located in Menlo Park, CA (US) and will be 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.
- Management and oversight of the Orchard Quality and Document Management Systems.
- Manage staff to administer and execute such quality programs as:
- Risk Management
- Nonconformance System
- Change Control
- CAPA Management
- Complaint Management
- Compliance Training
- Internal/External audits
- Key Performance Indicator Reporting for Management Review
- Supplier 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.
- Advanced degree preferred, e.g. MS or PhD in chemistry, cell biology, pharmacology, pharmacy or closely related field
- 15+ years of experience in a GxP biopharmaceutical manufacturing environment in a Quality or Compliance role
- 7+years management experience hiring, leading, managing and developing staff
- A resilient and visionary Quality Professional willing to pave a path
- Experienced leader in Quality Systems
- Working knowledge of US and EU GMPs, FDA/ICH Guidance, and QA best practices in a biotech manufacturing and testing environment
- Good understanding of the commercialization 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 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
- Willingness/availability to travel up to 10-15% (with some international travel)