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 oversees and directs all aspects of compliance, including laboratory operations, documentation, regulatory body inspections (e.g., FDA, Health Canada), supplier quality, third-party manufacturer quality, and strategic quality initiatives. This role engages 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 reviews.
• Own quality management systems for Deviation, CAPA, Change Control, Document Control, Annual Product Review Systems, Technical Services, and External Manufacturers (CMOs).
• Lead quality activities to execute production records, approve executed batch records, and support product release for shipment.
• Manage and improve ARI’s Quality Systems to ensure compliance with regulatory requirements and provide safe, effective products to customers.
• Ensure site-wide cGMP compliance in accordance with 21 CFR Parts 210 and 211, USP requirements, and other regulatory guidelines.
• Identify and facilitate the resolution of quality issues in conjunction with site teams.
• Manage all aspects of regulatory authority inspections, customer and corporate audits, development of responses, and execution of required improvements.
• Support metrics-based Continuous Quality Improvement activities and Key Performance Indicators (KPIs) through 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 harmonize policies and procedures.
• Promote a quality culture and Core Competency Model initiatives to enhance organizational performance.
• Oversee Quality Control (Stability, Chemistry, Microbiology, EM, & QC Particulate labs) for the site.
• Manage and facilitate QA Operations, QA Inspection, and Finishing teams to ensure timely and quality oversight of production activities.
• Partner with Production, Regulatory Affairs, Engineering, R&D, and QA Compliance to implement 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 company policies, cGMP, and health and safety requirements.
• Perform additional tasks/duties as assigned by management.

Requirements

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

Physical Environment and Requirements

• Occasionally required to stand, walk, sit, use hands to handle objects/tools, 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 gowns, goggles, face shields, and protective gloves.