Sr. Director of Quality Compliance

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. The incumbent will direct, consult, develop, implement, maintain, and ensure that the overall cGMP compliance profile is maintained effectively. This role will ensure the development and implementation of compliance processes and systems in a manner consistent with global quality systems requirements, corporate standards, current regulatory and client requirements. The role will engage effectively with health authorities and identify mechanisms to assure that our practices and policies meet current regulatory expectations. The incumbent will direct the quality notification to management program through escalation of quality events and the governing processes. The role will manage the DEA compliance, external and internal audit programs, and CMO audit requirements. The incumbent will lead continuous improvement programs and support compliance and risk activities.

We are seeking an ideal candidate who can establish a Quality Compliance strategy and direction throughout the organization. The incumbent will work to ensure continuous improvements regarding the most recent national and international cGMP compliance standards and to accomplish compliance in the most efficient way. The position will, develop and lead inspection readiness programs and provide guidance on all compliance related matters. They will advise on industry issues and regulatory changes that may affect PAI.

This role involves developing and implementing strategies to ensure compliance with regulatory standards, conducting audits and inspections, and managing quality-related issues to maintain the companys integrity and reputation. The incumbent ensures management reporting activities in compliance with Health Authority Quality System Regulation, other FDA & Health Authority Regulations, DEA and PAI policies and procedures. Additionally, as a subject-matter expert for auditing and inspection, training, quality escalations, and internal audits, Notified Body assessments, Health authority inspections, quality internal and external audits, adverse event reporting, post-market surveillance, and quality systems compliance.

This position is key in developing the compliance strategy within the PAI business and for Quality initiatives and escalating quality events to executive leadership as necessary through quality risk management principles and notification to management program.

Key Responsibilities:

• Develop and implement quality compliance programs and policies.
• Conduct internal and external audits to ensure compliance with regulatory standards and company policies.
• Quality Compliance and Internal Audit - Directs the activities for conducting internal audits across the Business Unit and manages all external 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. Notifies executive leadership through 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.

Post Market Surveillance:

• Directs the activities to comply with regulatory requirements for post-market surveillance of PAI products on the required schedule for adequacy of product instructions for use, risk management, performance and other key factors.

Compliance and Internal Audit:

• Directs the activities for conducting internal audits across the Business Unit and manages all external audits by Notified Bodies, FDA, DEA and other Competent Authorities.

Analytics:

• Directs the activities to ensure adequate trend analysis and statistical monitoring of internal quality compliance data, supplier data, manufacturing data and other key reports for regulatory requirements and PAI leadership visibility.

Representations and Responsibilities:

• Represents the Business, Site and Quality Department in a professional manner.
• Creates, reviews and approves Quality System Documents.
• Analyzes audit non-conformances and implements comprehensive & systemic corrective and preventive action plans.
• Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards / changes are incorporated into Quality strategy.
• Tracks and trends Quality Indicators.
• Interfaces with all PAI manufacturing facilities as well as other Business Unit functions.
• Executes on Quality Goals as approved by the Quality Leadership Team.
• Ensures maintenance all required records for the QMS.
• Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department.
• Provides leadership for the overall Quality Compliance Escalation & Notification to Management process and associated CAPAs.
• Analyzes 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.
• Develops, reviews and maintains Quality Policies.
• Reviews Quality audit reports and prepares appropriate corrective action responses.
• Establishes and leads an inspection readiness program. Provides on-site support for inspection management for key inspections.

Qualifications:

• Bachelor's degree in: Pharmacy, Chemistry, Biology, Chemical Engineering, or 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.
• Knowledge of systems and processes which support Quality management. Specifically, operational experience in the 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, 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 global QMS initiatives.
• Comprehensive understanding of auditing principles and ability to perform as a lead auditor. Experience with regulatory authorities from an auditing perspective with regulatory experience in a pharmaceutical GMP environment required.
• Knowledge of Quality best practices and experience with technology tools to support the Extensive knowledge of global quality regulations, industry or international standards and ability to interpret and implement.
• Ability to understand Regulatory, Business Unit and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency at the Business Unit & Plant levels.
• 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.
• The ability to engage in proactive communication to foster and maintain positive relationships internally and externally is essential, good negotiating skills.
• Understands basic applied statistics, statistical sampling plans, and statistical process control.
• Ability to serve in leadership capacity on projects or assignments.
• Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership techniques and project management methodologies.
• Broad expert knowledge of pharmaceutical, API, Aseptic, and OTC manufacturing processes and regulations.
• Excellent communication skills (verbal, written, and presentation). Understands how to present information to varying levels within the organization, including executive presence.
• Ability to effectively manage time and resources.
• Travel may be required at 40% for compliance audits.
• Ability to independently perform work of a broad nature.
• 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 with across global quality network. Listening, negotiating and effective communication skills under pressure are highly preferred. Business minded and customer focused.