Director/Senior Director, Quality Compliance

Director/ Senior Director, Quality Compliance

The Sr. Director of Quality Compliance directs Governance, Audit, Inspection, Escalation and Risk Management and is a valued member of the 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 the 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.

Responsibilities:

• Establish a Quality Compliance strategy and direction throughout the organization.

• Drive continuous improvement in alignment with the most recent national and international cGMP compliance standards.

• Ensure regulatory compliance is achieved in the most efficient manner.

• Develop and lead inspection readiness programs.

• Provide guidance on all compliance related matters.

• Advise the organization on industry issues and regulatory changes that may impact the company.

• Develop and implement strategies to ensure compliance with regulatory standards.

• Conduct audits and inspections.

• Manage quality related issues to maintain the company’s integrity and reputation.

• Ensure management reporting activities comply with: Health Authority Quality System Regulations, other FDA & Health Authority regulations, DEA requirements and company policies and procedures.

• Serve as a subject matter expert for: auditing and inspection, training, quality escalations, internal audits, Notified Body assessments, Health Authority inspections, quality internal and external audits, adverse event reporting, post-market surveillance and quality systems compliance.

• Play a key role in developing the compliance strategy across the business.

• Lead and support Quality initiatives throughout the organization and escalate quality events to executive leadership as necessary through quality risk management principles and notification to management program.

• 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 company 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 leadership visibility

• 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 manufacturing facilities as well as other Business Unit functions.

• Executes on Quality Goals as approved by the Quality Leadership Team.

• Ensures maintenance of 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), company 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.

• Act with integrity to advise collaboration with the operations team, driving continuous improvement to effectiveness and efficiency of quality systems processes, to deliver sustained compliance.

• Leads and oversees efforts to respond to new or changing regulations, including but not limited to communicating regulations to leadership and affected areas, assembling and chairing work teams, and developing/providing education regarding regulatory requirements and developing a closed loop program for the effective implementation of major regulatory changes.

• Ensures compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining Quality systems.

• Deliver safe & effective products and make Quality a competitive advantage by achieving an extraordinary GMP regulatory compliance with zero patient impacting events and drive quality strategy and culture.

• Attracts, develops and retains top talent to build an outstanding Compliance function. Implements the required interpersonal structures and operating mechanisms to maintain appropriate oversight of the compliance status of the business and achieve results.

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.

• 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 a 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.

• 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.

• Travel may be required at 40% for compliance audits.

• 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.

• Responsible for monitoring sponsored studies for compliance with company 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 and Compliance teams so that Quality Management Systems company 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 industry and dosage forms, proportionate, appropriate and sustainable.

• Responsible for daily management of Quality Compliance and Quality 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 audit processes and reporting requirements designed to support the functional area strategies that align with the principles and values of the company.

• Core competencies: Quality Assurance, Quality Risk Management, Quality Compliance Management, Quality Control, Process Improvement, Data Analysis, DEA and DSCSA Standards.