Quality Assurance Consultant

The Contractor, Product Quality is responsible for supporting GMP manufacturing, release, stability, and validation activities associated with development and commercialization of small-molecule assets. This function operates within a virtual (100% outsourced) business model will support batch disposition of drug substance, drug product, packaging, and labeling which will includes review/approval of protocols, methods, reports, and related GMP source documents.

The Contractor, Product Quality also works collaboratively with Technical Operations for Drug Substance/Drug Product/Bottling/Labeling for conformance with cGMPs, Quality Control to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.

* Support the compliance oversight of manufacture and analysis of Drug Substance and Drug Products and packaging and labeling of clinical and commercial supplies at Contract Manufacturing Organizations (CMOs).
* Support of all aspects of drug manufacture through clinical development and into commercial phase.
* Review and approve Master Batch Record (MBR) in compliance with GMP regulations, and regulatory submissions.
* Review and approval of executed batch records, analytical raw data, stability protocols, reports and data, and other documents to enable drug substance and final drug product release and on-going evaluation ensuring batches as GMP compliant.
* Review and approval of validation protocols, raw data, and reports (Method, Process, Cleaning, etc.).
* Perform data integrity and compliance assessments including review against source documentation for regulatory submissions (e.g., Module 3)
* Support of the internal Change Control, Deviation, and Quality Investigation systems
* Compile/archiving MBRs, EBRS, and associated batch release documentation