Sr Director of Quality Systems

Job Summary:

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. This role involves developing and implementing strategies to ensure compliance with QMS standards, engaging in audits and inspections, and managing quality-related issues and corrections to maintain the company's integrity and reputation.  

Additionally, the incumbent will as as a subject-matter expert for quality deviations, quality change control to market products and processes, quality lab investigation outcomes,  corrective and preventive actions, quality operations/plant quality daily, and quality systems compliance. This position is key in developing the QMS strategy within PAI and escalating quality investigations and change events to executive leadership as necessary through quality risk management principles.

Key Responsibilities:

•    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.

•    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. 

•    Analyzes internal quality systems and associated data to assure adherence to QSRs, DEA, and other international standards, corporate quality standards, and Business Unit and Facility quality standards.

•    Develops, reviews and maintains Quality Policies for the Business Unit.

•    Reviews Corporate Quality audit reports and prepares appropriate corrective action responses.

•    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.

Qualifications:

•    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 global QMS initiatives.

•    Comprehensive understanding of QMS principles and ability to perform as a global head for QMS practices. Experience with regulatory authorities 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 (ICH) and ability to interpret and implement. 

•    Ability to understand PAI, Business Unit and Plant Quality Systems and be able to 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.

•    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 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, DEA, API, and OTC manufacturing processes. 

•    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.

•    Ability to serve in leadership capacity on projects or assignments.

•    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:

•    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 international 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.

•    Responsible for monitoring the QMS for compliance with PAI quality standards, regulatory agencies requirements, and if applicable, global standards/requirements

•    Ensures that company products meet defined quality standards through management oversight 

•    Directs, initiates, plans, and develops processes and projects to define and implement quality assurance practices within manufacturing operations in line with organizational policies, standards, and guidelines. Ensures overall quality control of processes, raw materials, and products in line with regulatory and industry standards.    

•    Manage Quality Management System teams so that PAI sites are in compliance with all relevant legislation and controls; and relevant guidelines are fully addressed in a way which is relevant to our sector of the industry and dosage forms, proportionate, appropriate and sustainable.

•    Responsible for daily management of Quality Management System Escalations.  Develops and implements effective metrics and strategies to support daily operations, provides strategic quality oversight of pharmaceutical operations with direct responsibility for Quality Assurance and matrix responsibility for Quality Control activities.  Works closely with overall leadership to develop and drive business, site, and quality strategic objectives.

•    Initiates, plans, and develops processes and projects to define and implement quality assurance practices within manufacturing operations in line with organizational policies, standards, and guidelines. Ensures overall quality control of processes, raw materials, and products in line with regulatory and industry standards.

•    Directs and manages QMS processes and reporting requirements designed to support the functional area strategies that align with the principles and values of PAI. 

•    Develops data and support the PAI Quality Management Review Process

•    Quality Assurance

•    Quality Risk Management 

•    Quality Compliance Management

•    Quality Control

•    Deviation Management

•    Laboratory Investigation Management

•    Quality Control Investigations

•    Global Quality Change Control

•    Process Improvement

•    Data Analysis

•    DEA Standards