QA Manager, Orchard Therapeutics
Quality Management Systems & Vendor Oversight
Biotechnology company specialising in innovative gene therapies
Job no longer available
Biotechnology company specialising in innovative gene therapies
201-500 employees
Job no longer available
201-500 employees
Company mission
Dedicated to transforming the lives of patients with inherited diseases through innovative gene therapy.
Role
Who you are
- Bachelor's degree or equivalent education and work experience
- Professional with a minimum of 5 years of experience in Quality Assurance role in pharma, biopharma/biotech, or healthcare environment
- Must have proficient computer skills in Microsoft Word, Excel and Outlook
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused entrepreneurial environment
- 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
What the job involves
- This role will report to the Director Corporate Quality, located in Boston, MA (US) and will be responsible for the management of the Orchard Quality Management System (QMS) to ensure compliance with applicable US and EU Good x Practice (GxP) standards and requirements
- This role will also be responsible for vendor oversight activities including risk assessments ensuring vendors utilized by the company are appropriately qualified
- Management and oversight of the Orchard Quality Management Systems
- Manage and oversees day-to-day maintenance of Orchard Quality System elements, including but not necessarily limited to Deviation, CAPA, OOS, Complaint, and Change Control
- External vendor due diligence activities including qualification audits
- Participate in, support and represent the Quality Management System in internal management reviews as well as in regulatory and third-party inspections at Orchard
- Lead Vendor Management Quality function
- Support Risk Assessments for Orchard vendors to ensure appropriate qualification activities are conducted
- Write, revise and periodically review SOPs to further develop the Quality System and control over the quality of vendor services and products
- Assist in the development and tracking of Quality metrics (KPI). Prepare metrics for the Management Review and Annual Product Review
- As appropriate, attend project meetings and lead the resolution of quality-related issues
- Clearly communicate issues to vendors and Orchard Therapeutics management in a timely basis
- Supports the preparation, coordination, and management of regulatory agency Preapproval or regular inspections
- Support regulatory inspections; internal and external
- Reporting to: Director Corporate Quality Assurance
Salary benchmarks
Our take
Orchard Technologies is a biotechnology company that specialises in developing gene therapies for serious and life-threatening illnesses. Based in London and Boston, the company went public on the NASDAQ exchange in 2018, reaching a $1b valuation and becoming a unicorn in the process.
In 2018, Orchard acquired GSK’s rare disease gene therapy portfolio, endowing the firm with one of the deepest and most advanced gene therapy product candidate pipelines in the industry. Today, the portfolio spans multiple therapeutic areas where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist.
In light of COVID-19, the company had to lay off 25% of its workforce and change tack, instead focusing on more common conditions, including Crohn’s disease, some types of dementia and some neurometabolic disorders. Longer term, there are many challenges for Orchard ahead, the main being to make gene therapy for rare diseases profitable.
Kirsty
Company Specialist at Welcome to the Jungle
Insights
11% employee growth in 12 months
Company
Funding (last 2 of 4 rounds)
Aug 2018
$150m
Dec 2017
$110m
Total funding: $308.3m
Company benefits
- Work from home opportunities
- Health insurance
Company HQ
City of London, London, UK
Leadership
Bobby Gaspar
(CEO)Bobby Gaspar is a Professor of Paediatrics and Immunology who founded the company and started out as the Chief Scientific Officer before becoming CEO. His interests lie in the treatment of severe primary immune deficiencies and he was the pioneer in trials of bone marrow transplantation
Andrea Spezzi
(Chief Medical Officer)Andrera Spezzi is Physician/Paediatrician and Specialist in Pharmaceutical Medicine with vast experience in a variety of global roles. He has managed research and development from discovery stage to registration and launch and also offers valuable input in marketing and medical affairs activities
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