Associate Director R&D QA
Boston, MA 02111
Our client is looking to immediately place a Manager of R&D QA; Pharma Experience is Required.
- Support the Quality Assurance, Quality Control, and Analytical Services Divisions.
- Ensure compliant phase appropriate cGMP operations are continuously maintained across the site leading up to project turnover to commercial production.
- Support a partnership with the Quality unit charged with the review and management of departure investigations (i.e., root cause analysis, product impact assessments, and CAPA), GMP document review, on-floor batch review, batch disposition, and also supporting phase appropriate quality oversight during technology transfer.
- Play a vital role during regulatory agency inspections and client audits as pertaining to R&D/clinical products and processes.
- Establish and maintain a risk-based and scientific-based phase appropriate quality system to protect the public health and to meet business needs.
- Oversee, and be ultimately responsible for, the R&D business unit’ s quality assurance program. This includes overseeing and assisting with the Company’ s training and auditing programs, as well as the review of SOPs, investigations, specifications, methods, validation/ verification reports, analytical reports, and manufacturing records
- Must have a Bachelor’ s Degree in Life Sciences or related field
- Must have 8+ years of experience in the Pharmaceutical industry, with at least 5 of those years being experience in Quality.
- Must have experience in aseptic fill/ finish and sterility assurance programs.
- Must have experience in clinical quality assurance
- Must have Solid knowledge in FDA and global regulations, especially the cGMP for the 21st century initiatives