Sr. Director of Quality Systems

The Senior Director Quality Systems holds responsibility for Quality Operations (Plant Quality), Deviations, CAPA, Change Control, Lab Investigations, and Document Control. The incumbent is responsible to direct, consult, develop, implement, maintain, and ensure that the overall cGMP quality is responsible for overseeing the quality management systems within PAI. This role involves developing and implementing strategies to ensure compliance with regulatory standards, managing quality deviations and CAPAs, overseeing global quality change control processes, and governing lab investigations to maintain product quality and safety.

This role will ensure the development and implementation of QMS processes and systems in a manner consistent with quality management systems requirements, PAI standards, current regulatory and CMO/client requirements. The role will engage effectively with all PAI sites and with competent health authorities and identify mechanisms to assure that our practices, policies, and quality investigations meet current regulatory expectations.

We are seeking an ideal candidate who can establish a Quality Management System strategy and direction throughout the organization meeting all cGMP compliance requirements for quality investigations, change control and corrective/preventive actions using risk based approaches and tools. The incumbent will work to ensure continuous improvements regarding the most current cGMP compliance standards and to ensure a robust QMS program in the most efficient way.

The position will, develop and lead global QMS programs and provide guidance on all corrective action related matters. They will advise on relevant standards that may affect the overall quality management review process.

• Develop and implement global quality management systems, including deviations, CAPA, change control, and lab investigations.
• Govern and manage quality operations to include plant product inspection, quality release, labeling, and be a functional point person for investigations and improvements for quality at a plant floor level
• Conduct internal and external audits to ensure compliance with regulatory standards and company policies.
• Collaborate with cross-functional teams to implement quality compliance corrective and preventive actions (CAPAs).
• Oversee change control processes and ensure proper documentation and approval of changes. Direct the global change control review board for PAI
• Manage deviations and CAPAs to identify root causes and implement corrective actions.
• Monitor and review quality assurance and quality control data to identify trends and areas for improvement.
• Conduct lab investigations to address quality issues and ensure product safety.
• Prepare and maintain documentation related to deviations, change control, investigations, lab, and CAPA activities.
• Provide training and support to employees on QMS practices and electronic system (eQMS) use supporting the QMS
• Stay updated on industry regulations and standards to ensure ongoing compliance.
• Monitor and review quality control data to identify trends and areas for improvement.
• Prepare and maintain documentation related to quality systems, deviations, CAPAs, change control, and lab investigations.
• Govern the Quality Document Control process and Learning Management Curricula. Creates, reviews and approves Quality System Documents.
• Analyzes audit non-conformances and implements comprehensive & systemic corrective and preventive action plans.
• Tracks and trends Quality Indicators.
• Interfaces with all PAI manufacturing facilities as well as other Business Unit and Corporate functions.
• Provide training and support to employees on quality systems and procedures.
• Stay updated on industry regulations and standards to ensure ongoing compliance.
• Act with intensity to advise collaboration with the operations team, driving continuous improvement to effectivity and efficiency of quality systems processes, to deliver sustained compliance.
• Report to senior management on quality systems, deviations, CAPAs, change control, lab investigations, and document control activities and progress.

• Bachelor's degree in:
  Pharmacy, Chemistry, Biology, Engineering or a related field.
• Minimum of 15 years of experience in quality assurance, quality control, or risk management within the pharmaceutical industry.
• Knowledge of systems and processes which support Quality Management System. Specifically, operational experience in the core QMS processes such as quality change control, deviation handling, quality control, document control, learning management, and corrective and preventive action management
• Demonstrated excellent interpersonal, written and verbal communication skills, and demonstrated ability to prepare written reports, correspondence and presentations to senior leadership.
• Experience recognizing the broad, systemic implications of problems and issues and demonstrated experience with negotiating win-win solutions for a broad range of…