Establishes the vision and oversees the global regulatory compliance strategy, objectives, policies and programs supporting the development, manufacture, testing and distribution of 40+ commercial products and 40+ clinical products distributed in 100 plus countries around the world. Serve as the leading source of Quality Regulatory Compliance-related expertise and decision making in the global organization and is responsible for providing strategic leadership, support and collaboration to ensure all systems, processes, products and their outcomes comply with applicable international and national standards, regulations, and guidelines. Provides strategic leadership and program direction to develop, implement and continuously improve enterprise-wide GMP/GDP compliance.
This role is accountable for proactively improving Shire's quality and compliance position as well as strengthening Shire's regulatory reputation externally and throughout the life sciences industry. Acting as an independent review and evaluation body to ensure that compliance concerns across Shire are being appropriately evaluated, investigated and resolved. This role routinely provides updates on Shire's compliance performance and escalation of quality compliance risks to the CEO, Executive Team, Tech Ops Leadership Team and Quality Leadership Team.
Executes the risk officer role for Shire Tech Ops Quality. Enabling efficient, effective governance of significant risks and instituting management controls to assess, manage and escalate risks to Shire's Tech Ops Leadership Team, Shire's Executive Committee and Shire's Board of Directors for enterprise risk review.
Oversees the regulatory intelligence internal/external to Shire to identify and analyze new GMP/GDP enforcement requirements and trends to set strategic priorities, inform product lifecycle decisions and influence external regulator policy decisions, including responses to ad hoc queries from executive leadership (TOLT), product teams, and other stakeholders. Engages in proactive relationships with FDA and international regulatory authorities as appropriate to present and defend strategies and approaches to facilitate the advancement of Shire's goals and objectives.
Manages the design and execution of Shire's Quality Management System through the deployment of the Quality Manual and Global Quality Standards. Develops and oversees enterprise wide systems for the timely detection, response, investigation, analysis of quality compliance-related issues to influence product strategy and execution; provide technical input to investigations, regulatory notifications and inform regulatory agency responses/meetings.
As a member of the Quality Leadership Team, actively supports the supply value proposition and cultural elements of mutual accountability, continuous improvement and creation of a learning organization.
- Sets strategy to enhance and execute the following programs to acquire, manage and use regulatory compliance and quality knowledge globally: quality manual & global quality standards, supplier quality management, business intelligence & operations, risk management, quality governance & product quality management, internal audit, regulatory inspection management, GMP/GDP inspection readiness, regulatory intelligence, due diligence and integration, regulatory authority policy and industry trade groups, regulatory compliance center of excellence, quality communication & employee engagement. Provide strategic thinking, the vision and results-oriented leadership to build a world-class organization and establish a robust, efficient and compliant Quality Management System.
- Sets the quality compliance strategy commensurate with the overall plan for the company which includes further expansion into Europe and ROW with global supply chain and distribution activities. Ensure alignment with customer needs and linkage with strategies.
- Provides strategic vision & expertise for establishing and managing the corporate quality audit program (GMP/GDP) to holistically assess the state of regulatory and quality compliance of Shire's network of internal manufacturing sites, legal entities, external suppliers worldwide spanning across multiple operating units, center / corporate functions and countries.
- Oversees the Global Quality Manual & Global Quality Standards Programs to ensure effective identification, control and management of regulatory and operational requirements, ensuring that all applicable laws, regulations as well as corporate requirements are addressed.
- Advises on strategies and tactical measures for maintaining a state of robust global GMP/GDP compliance within Shire's internal manufacturing network, global supply chain & distribution network. Maintains expert knowledge of the competitive/regulatory landscape and Shire's key challenges. Analyzes the strategic significance of recent past and forthcoming regulatory events and their potential impact on the Shire portfolio.
- Oversees a comprehensive enterprise risk management program reflective of Shire's philosophy and approach to assessing and managing risk.
Education & Experience Requirements: Essential:
- Ensures appropriate Quality leadership of all partner and regulatory authority audits and inspections and corrective action programs in response to observations.
- Lead efforts for GMP/GDP inspections and collaborate with all internal and external partners to ensure readiness of all GCP, GPVP regulatory inspections.
- Establish and maintain a positive working relationship as a thought leader with FDA and other regulatory authorities. Represent Shire both internally and externally on any Quality and compliance issues. Lead and participate in industry trade groups to influence regulatory authority policy decisions externally to Shire.
- Provide expertise and guidance in interpreting government regulations and guidelines as they apply to products and practices. Oversees a compliance data analytics program to monitor business activity for compliance with applicable regulatory requirements, identify key risk indicators, timely identify, escalate and mitigate compliance risks.
- Quality representation on cross-functional Technical Operations Subteams, R&D Risk Committee and Aligned Assurance Forum, providing direction on business plans, regulatory submissions, strategic projects and operational requests with authority to make compliance-related decisions. Builds strong relationships across the operating network including; Operational Unit Leadership for Small Molecules, Biologics, Devices and Plasma, Quality Leadership Team, Executive Leadership (TOLT) and legal counsel. Works with other senior management in the enterprise to create and maintain policies, procedures and quality control to ensure compliance with applicable GMP/GDP regulations.
- Drive the organization to establish and continually improve best in class processes and practices. Promote the development of a company-wide understanding of the key elements related to quality system and regulatory compliance.
- Develop and execute Quality strategy and goals commensurate with the overall plan for the company, including supply chain and distribution activities. Manage the tracking and trending of department performance and quality indicators and make improvements and adjustments as required. Provide strategic input to the annual and long-range planning and budgetary process ensuring timely, effective use of resources
- Recruit, retain and develop first class talent responsible for providing Quality Compliance, Risk Management and Business Intelligence support to all Shire operations. Build and sustain employee engagement by fostering a culture of timely decision making, execution and a coaching environment in which individuals and teams can excel and continuously grow.
- Effectively lead and manage quality personnel at the Sr Director level and below in multiple global locations. Participates as a member of the Quality Leadership Team to manage and oversee all aspects of the organization's performance including Human Resource development, technical performance, ongoing Quality initiatives and Operational Excellence.
- As a member of the Tech Ops L3 Leadership team, provide sound advice and guidance regarding the impact of regulatory and quality issues on overall corporate strategy and operations.
- Champion cultural and business change associated with achieving and implementing Shire's long range strategy and strategic initiatives. Foster cooperation across team and multiple operating units and sites across the globe. Builds consensus and morale through understanding of underlying team dynamics and by promoting development of team relationships.
Bachelor's Degree in Pharmacy, Science or Engineering. Minimum of 15 years professional working experience in pharmaceutical manufacturing, Quality Control, Quality Assurance, CMC, Regulatory or related compliance experience with at least 10 years aggregate experience leading Quality programs and or performing audits for in the drug, device, biologics or plasma industry. Minimum of 5+ years of experience in a senior leadership role with a proven ability to effectively lead and manage a global team. Must possess sound knowledge of applicable cGMP regulations and expectations sufficient to readily interpret, lead discussion, and provide guidance (as necessary) based on the applicability of the regulations to the subject being evaluated. Must be familiar with all other GMP/GDP concepts and global regulations (FDA, MHRA, WHO etc.)
- Ability to read and interpret comprehensive regulations, guidance documents, policy changes and HA inspection observations and responses. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization
- Ability to critically evaluate and provide robust verbal and written responses to Health Authority responses/observations
- Ability to effectively lead global teams
- Proven ability to work effectively with senior leadership
- Track record of inclusive talent development and mentorship that resulted in improved business performance and growth opportunities for employees
- Demonstrate practice of constructive engagement and the confidence to challenge and be challenged to get the best strategies and solutions
- Advanced degree in related field
Domestic and international travel up to 25% for business meetings with local staff, corporate peers/collaborators, industry trade groups and to stay current with evolving regulatory trends and expectations.