Sr. Director of Quality Compliance

About the Role

The Sr. Director of Quality Compliance directs Governance, Audit, Inspection, Escalation, and Risk Management and is a valued member of the PAI Quality Leadership team. This role ensures the development and implementation of compliance processes and systems consistent with global quality systems requirements, corporate standards, current regulatory, and client requirements. The incumbent will engage with health authorities, lead continuous improvement programs, and support compliance and risk activities.

Responsibilities

• Develop and implement quality compliance programs and policies.
• Conduct internal and external audits to ensure compliance with regulatory standards and company policies, including audits by Notified Bodies, FDA, DEA, and other Competent Health Authorities.
• Oversee inspection processes and ensure readiness for regulatory inspections.
• Manage escalation processes to address and resolve quality issues promptly, including notifying executive leadership through the corporate quality escalation program.
• Direct and communicate Notification to Management regarding escalated quality events.
• Collaborate with cross-functional teams to implement quality compliance corrective and preventive actions (CAPAs).
• Monitor and review quality assurance and quality control data to identify trends and areas for improvement.
• Prepare and maintain documentation related to compliance, audit, inspection, and escalation activities.
• Provide training and support to employees on quality compliance and audit practices.
• Stay updated on industry regulations and standards to ensure ongoing compliance.
• Report to senior management on quality compliance, audit, inspection, and escalation activities and progress.
• Direct post-market surveillance activities to comply with regulatory requirements for PAI products.
• Ensure adequate trend analysis and statistical monitoring of internal quality compliance data, supplier data, manufacturing data, and other key reports.
• Represent the Business, Site, and Quality Department professionally.
• Create, review, and approve Quality System Documents.
• Analyze audit non-conformances and implement comprehensive and systemic corrective and preventive action plans.
• Participate in trade and/or professional organizations to incorporate state-of-the-art industry standards/changes into Quality strategy.
• Track and trend Quality Indicators.
• Interface with all PAI manufacturing facilities and other Business Unit functions.
• Execute on Quality Goals as approved by the Quality Leadership Team.
• Ensure maintenance of all required records for the QMS.
• Ensure the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out department responsibilities.
• Provide leadership for the overall Quality Compliance Escalation & Notification to Management process and associated CAPAs.
• Analyze internal quality systems and associated data to assure adherence to QSRs, DEA, and other international standards (ICH), PAI quality standards, and Business Unit and Facility quality standards.
• Develop, review, and maintain Quality Policies.
• Review Quality audit reports and prepare appropriate corrective action responses.
• Establish and lead an inspection readiness program.
• Provide on-site support for inspection management for key inspections.
• Act with integrity to advise collaboration with the operations team, driving continuous improvement to the effectiveness and efficiency of quality systems processes.
• Lead and oversee efforts to respond to new or changing regulations, including communicating regulations to leadership, assembling and chairing work teams, and developing/providing education regarding regulatory requirements.
• Ensure compliance with all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining Quality systems.
• Deliver safe and effective products, making Quality a competitive advantage by achieving extraordinary GMP regulatory compliance with zero patient-impacting events and driving quality strategy and culture.
• Attract, develop, and retain top talent to build an outstanding Compliance function.
• Implement required interpersonal structures and operating mechanisms to maintain appropriate oversight of the compliance status of the business and achieve results.
• Monitor sponsored studies for compliance with PAI quality standards, regulatory agencies requirements, and global standards/requirements.
• Ensure that company products meet defined quality standards through management oversight.
• Direct, initiate, plan, and develop processes and projects to define and implement quality assurance practices within manufacturing operations in line with organizational policies, standards, and guidelines.
• Ensure overall quality control of processes, raw materials, and products in line with regulatory and industry standards.
• Manage Quality and Compliance teams so that Quality Management Systems at PAI sites comply with all relevant legislation and controls, addressing relevant guidelines in a proportionate, appropriate, and sustainable way.
• Responsible for daily management of Quality Compliance and Quality Escalations.
• Develop and implement effective metrics.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Chemical Engineering, or a relevant discipline.
• Minimum of 15 years of experience in quality assurance, quality control, or risk management within the pharmaceutical industry at a senior leader level.
• Operational experience in core QMS processes such as document management, change control, deviation handling, quality control, good distribution practices, supplier quality management, and escalation to management processes.
• Demonstrated excellent interpersonal, written, and verbal communication skills, including the ability to prepare written reports, correspondence, and presentations to senior leadership.
• Experience recognizing the broad, systemic implications of problems and issues, and demonstrated experience negotiating win-win solutions for global QMS initiatives.
• Comprehensive understanding of auditing principles and ability to perform as a lead auditor.
• Experience with regulatory authorities from an auditing perspective in a pharmaceutical GMP environment.
• Extensive knowledge of global quality regulations, industry, or international standards and ability to interpret and implement them.
• Ability to understand Regulatory, Business Unit, and Plant Quality Systems and implement systemic changes to enhance product quality and improve business efficiency.
• Ability to interface with regulatory bodies to defend quality compliance.
• Proven leadership ability and experience building and maintaining positive relationships globally, both internally and externally.
• Understanding of basic applied statistics, statistical sampling plans, and statistical process control.
• Ability to serve in a leadership capacity on projects or assignments.
• Broad expert knowledge of pharmaceutical, API, Aseptic, and OTC manufacturing processes and regulations.
• Excellent communication skills (verbal, written, and presentation) with the ability to present information to varying levels within the organization, including executive presence.
• Strong knowledge of GMP, regulatory requirements, and quality management systems.
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office Suite and quality management software.

Skills & Competencies

• Knowledge, experience, and skills with quality assurance functions and the use of information technology platforms.
• Track record of strong involvement with industry professional associations is preferred.
• Capability to network within the pharma industry and partner strategically with health authorities/regulators.
• Industry experience in applying predictive analytics and big data/artificial intelligence to create predictive indicators of quality manufacturing.
• Capability to collaborate effectively across a global quality network.
• Listening, negotiating, and effective communication skills under pressure are highly preferred.
• Business-minded and customer-focused.

Schedule

Travel may be required at 40% for compliance audits.