Manager, Quality Assurance - GxP (GCP Auditing) Remote
Axsome Therapeutics Inc- Full Time
- Junior (1 to 2 years)
Candidates should possess an M.Sc. or B. Pharm.Des., and have between 6 and 10 years of experience. A strong understanding of cGMP, cGLP, and other regulatory requirements is essential, along with experience in laboratory operations.
The Senior Executive Quality Assurance will ensure the effective implementation of quality systems and procedures, monitor compliance with regulatory requirements, participate in investigations of laboratory errors and incidents, handle QMS through SolTRAQs, ensure compliance to EPD Global Guidelines, and act as a laboratory compliance administrator. They will also face internal and external audits, implement GLP/GMP requirements, coordinate practices with COBC requirements, and address market complaints and out-of-specification results.
Healthcare solutions in diagnostics and devices
Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.