Senior Director Quality Affairs

About the role

Reporting to the Senior Director of Quality, this multi-disciplinary management role interacts with all phases of production for the manufacture of sterile injectables. The position provides oversight and direction for all aspects of compliance, including laboratory operation, documentation, regulatory body inspections (e.g., FDA, Health Canada), supplier quality, third-party manufacturer quality, and strategic quality initiatives and continuous improvement processes. This role interacts with all levels of the organization both domestically and internationally.

Responsibilities

• Provide leadership and direction for a professional team focused on quality management systems and compliance; establish and maintain performance goals, training plans, and provide regular feedback, including performance plans and reviews.
• Own quality management for Deviation, CAPA, Change Control, Documentum Control, Annual Product Review Systems, Technical Services, and External Manufacturers (CMOs).
• Lead quality activities to execute production records, approve executed batch records, and support release of product for shipment.
• Manage and improve ARI’s Quality Systems to ensure compliance with regulatory requirements and provide safe and effective products to customers.
• Ensure site-wide cGMP compliance in accordance with 21 CFR Parts 210 and 211, USP requirements, and other regulatory requirements.
• Identify and facilitate the resolution of quality issues in conjunction with site teams.
• Manage all aspects of regulatory authority inspections and customer and corporate audits, including development of responses and execution of required improvements following such inspections/audits.
• Own and support metrics-based Continuous Quality Improvement activities and Key Performance Indicators (KPI) through application of statistical methodology.
• Provide oversight for review and release of commercial, R&D, and clinical study products.
• Maintain and manage communications and cross-functional activities with internal/external customers and regulatory agencies.
• Drive continuous improvement initiatives for the site and work with other ARI locations to assure best practices and harmonization of policies and procedures.
• Promote quality culture and core competency model initiatives in support of enhanced organizational performance.
• Oversee Quality Control (Stability, Chemistry, Microbiology, EM, & QC Particulate labs) for the site.
• Manage and facilitate the QA Operations, QA Inspection, and Finishing team to assure timely and quality oversight of production activities related to manufacturing, filling, transfers, inspection, and packaging of sterile injectable drug products.
• Partner with Production, Regulatory Affairs, Engineering, R&D, and QA Compliance to strategize and organize implementation of new technology, processes, and products.
• Lead on-site QA activities in investigating deviations, CAPAs, or other compliance issues associated with daily inspections/packaging operations.
• Write and revise SOPs and other cGMP documentation.
• Ensure all work is performed and documented in accordance with existing company policies and procedures, as well as cGMP and health and safety requirements.
• Perform any other tasks/duties as assigned by management.

Requirements

• Bachelor’s degree in Life Science or equivalent course of study required; Master’s Degree is a plus.
• Minimum 15 years of progressive experience in pharmaceutical operations and interactions with regulatory agencies.
• Minimum 10 years of experience leading functional quality assurance, quality control, compliance, or manufacturing operations.
• Expertise across multiple areas, including developing quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities, and validation for pharmaceutical manufacturing facilities.
• Thorough understanding of applicable regulations/guidelines/expectations and proven ability to apply them to a pharmaceutical environment.
• Proven excellence in written and verbal communication skills.
• Proven record of exceptional people and program management skills.
• Ability to work independently and deliver timely results.
• Ability to work off-hours and weekends as needed.
• Able to travel 10% of the time.

Physical Environment and Requirements

• While performing duties of the job, incumbent is occasionally required to stand, walk, sit, use hands to finger, handle or feel objects, tools, or controls, reach with hands and arms, balance, talk, and hear.
• Must be able to occasionally lift and/or move up to 25 pounds.
• Physically able to wear cleanroom/protective gowning and equipment, including gowning, goggles, face shields, and protective gloves.