Senior Manager Quality Assurance Operations

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The Senior Manager of Quality Assurance Operations will support the Quality Assurance department including oversight of cGMP operations performed at Contract Manufacturing Organizations (CMOs), as well as cGMP operations performed at Acadia, for all products intended for commercial and clinical (where required) use.  Primary responsibilities include batch record review and batch disposition, support of Product Complaints, Annual Product Review, Continuous Process Verification (CPV), ensuring conformance to Acadia Standard Operating Procedures (SOPs) and Quality Agreements with CMOs, as well as compliance with FDA and applicable international regulations.  Participate in continuous improvement activities with respect to Acadia GMP training program, change management, deviation investigations, CAPA program, GMP audits, and similar related activities.

Primary Responsibilities

• Manages the batch disposition process for all Acadia drug product and substance production
• May serve as a key point of contact with CMO partners and ensures integrated, coordinated activities related to cGMP production and continuous improvement
• Leads or participates in formal risk assessment activities
• Provides on-site quality support at CMOs as required
• Participates in the design, implementation and management of the Acadia GMP quality management system, based on FDA and applicable international regulations
• Ensures compliance of the Acadia GMP quality management system with FDA and applicable international quality management system regulations
• Participates in GMP supplier audits and Acadia documentation control systems
• Participates in the review of, and ensures conformance to, Quality Agreements with GMP contract service providers for outsourced operations
• Provides guidance to SMEs and acts as QA lead on investigations, change management and batch record review, and establishing effective CAPA plans
• Participates in and/or leads QA in continuous improvement of Acadia quality management systems according to GMP and current industry standards
• Ensures adequate QA representation on all GMP commercial manufacturing, supply chain, and product development teams
• Recommends changes to policies and establishes procedures that affect the functional area and may also have company-wide effect
• Participates in Quality Operations functions, such as: Material Review Board, quality board, strategic efforts, etc., as required by Acadia Management
• Develops and/or contributes metrics to support product and/or process review efforts as needed.
• Other duties as assigned/required

Education and Experience

• Bachelor’s degree in Chemistry, Biology or related life science required. Equivalent combination of relevant education and applicable job experience may be considered 
• Targeting 8 years in a Quality Assurance role  with progressively responsible experience within the pharmaceutical or biopharmaceutical industry. Professional certifications from the American Society for Quality (ASQ) a strong plus
• Demonstrated knowledge of Quality Assurance activities and International Conference on Harmonization (ICH) and FDA/EU GMP regulations as they relate to clinical trials, product development, commercial requirements and technology transfer
• Ability to lead a cross-functional team to develop solutions to a complex problem or advance a continuous improvement or preventive action opportunity
• Experience implementing and managing quality management systems
• Demonstrated proficiency in interpretations of cGMP regulations, both US and international
• Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines
• Experience conducting internal and supplier audits and manufacturing facility inspections
• Ability to interpret and relate Quality standards for implementation and review
• Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals
• Able to make and prioritize process and resource decisions based on overall team and organizational needs
• Ability to travel 20%

Physical Requirements

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 and independently from remote locations.  Employee must occasionally lift and/or move up to 20 pounds.   Ability to travel independently overnight up to 20% of the time and work after hours if required by travel schedule or business issues.

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