QA Manager: Quality Management Systems & Vendor Oversight
Boston , MA 02108
Posted 2 months ago
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Manager, Quality Management Systems & Vendor Oversight, Corporate QA
Location: Boston, US
Reporting to: Director Corporate Quality Assurance
Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Created three years ago, it is in an exciting 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 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
- 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
For further information on this role do not hesitate to email HR@orchard-tx.com
All employment offers and CVs 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.