Lexicon Pharmaceuticals is currently searching for an agile, results focused GMP Quality Assurance Manager to join our Quality Assurance team in The Woodlands, Texas or Basking Ridge, New Jersey.
The GMP Quality Assurance Manager will oversee all the quality activities at domestic and international CMO sites for API and intermediate production of Lexicon’s products.
Responsibilities include, but are not limited to:
- Manage the quality aspects of the API and intermediate production at domestic and international CMO sites, activities including reviewing and approving master batch records, executed batch records, deviations, change controls, and investigations associated with productions.
- Manage the quality aspects of the QC testing, activities including reviewing and approving analytical methods, change controls, OOS investigations, stability protocols, and stability reports.
- Manage the method validation activities by reviewing and approving method validation protocols, and reports.
- Manage the process validation activities by reviewing and approving validation master plan, risk assessment, process performance qualification protocols, process performance qualification reports, revalidation protocols, and reports.
- Manage the overall vendor performance by monitoring the key performance indicators.
- Review and approve vendor Annual Product Reviews
- Support other activities in quality system as needed, e.g, internal audits, regulatory inspections, and SOP development etc.
- Manage to turn around production documents from CMOs within limited time constraints.