Quality Assurance Senior Specialist
The QA Specialist will provide expert QA support to Orchard Therapeutics’ innovative cell and gene therapy product programs. This individual will be tasked with the implementing quality and compliance for GXP activities at the company, including the manufacture and delivery of gene-modified cell-based at contract manufacturing organizations. Such responsibilities will encompass company’s therapeutic programs from pre-clinical research through to commercial.
- Reviews executed batch, records, test records and associated documentation for release of gene-modified cell therapy products
- Reviews documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports that are submitted to QA for approval
- Performs internal and external audits
- Utilizes Operational Excellence tools such as FMEA, DMAIC and root cause analysis for review and investigations within Orchard’s QMS
- Interprets and implements quality procedures
- Conducts new hire training
- Assists in the generation of QMS Metrics
- Other duties as may be assigned
The ideal candidate for this position will have in-depth experience of QA systems in support of biologic product development and commercialization.Candidate must possess:
- A minimum BS in biological sciences or a related discipline
- QA experience in the biotechnology or pharma industry, ideally with innovative biologic products
- Proven track record of successful interaction with Contract Manufacturing Organizations and Contract Testing Organizations up to and including commercial production
- In-depth knowledge and proven application of FDA, EU, CGMP and ICH regulatory requirements
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.