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.
Bachelor’s degree in chemistry/life sciences required, Master’s degree a plus.
5-10 years of work experience in the pharmaceutical industry
Minimum of 5 years of work experience in analytical chemistry or process chemistry.
In depth knowledge and hands-on experience in GMP regulations, quality systems, quality assurance, quality control, validation.
Ability to communicate effectively (verbally and in writing) with internal and external customers and excellent presentation skills.
Proficiency with Microsoft Office (Excel, Word, Project, PowerPoint). Experience with MasterControl or TrackWise is preferred.
Proficiency in foreign languages (Chinese, Italian, or German) is a plus.
Ability and desire to work effectively in a team environment.
Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science, based on Nobel Prize-winning technology, to discover and develop precise medicines for patients with serious, chronic conditions.
Our world class research and commercialization teams are located in Basking Ridge, New Jersey and The Woodlands, Texas. Lexicon employees are inspired by the ...idea that their work can improve patients' lives and we know that our employees are important to the success of our mission. We are dedicated to making Lexicon a great place to work by providing employees with the benefits, services, and programs which will allow them to reach their full potential.