Principal Solutions Architect
•Soloioinc· 5h
💻 Engineering⏰ Full-time🎯 Lead / Principal🇺🇸 USA
5h ago
Acadiapharmaceuticals·about 8 hours ago
On behalf of Acadia GmbH the Sr. Manager, Quality Assurance Operations will be responsible for oversight of cGMP European operations within a global Quality Assurance department of Acadia Pharmaceuticals Inc. Responsibilities will include oversight of assigned cGMP operations performed at Contract Manufacturing Organizations (CMOs), as well as cGMP European operations performed at Acadia, quality release of API and drug product, raw materials and intermediates intended for commercial and clinical (where required) use. Primary responsibilities include: batch record review and batch disposition, support of product complaints, annual product review / product quality reviews, continuous process verifications (CPV), ensuring conformance to global Acadia standard operating procedures (SOPs) and quality agreements with CMOs, as well as compliance to Swissmedic/EMA/MHRA and other applicable international regulations. Proficient-level user and participant in continuous improvement activities with respect to Acadia global GMP training program, change management, validation activities, batch review and release, complaint handling, CAPA program, GMP audits, and similar related activities. This position reports to the Director, Quality Assurance, Acadia GmbH.
Pharm D, Master´s or Bachelor’s degree in Chemistry/Biology/Pharmacy or related life science is required. A minimum of 5 years related and progressively responsible experience within the pharmaceutical or biopharmaceutical industry.
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds. Ability to travel by car or airplane independently up to 20% of the time and work after hours if required by travel schedule or business issues.
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What we offer US-based Employees:
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