Global Quality – Global Quality Systems
Head, Quality Standards and Learning Management
Role Summary
The incumbent will lead the design and integration of the Quality Management System framework (including regulatory content) and its implementation across the product lifecycle from development through product divestiture or deletion. The scope of the role will be in support of an enterprise wide QMS across the GxPs inclusive of ensuring adherence to Good Laboratory Practices (GLPs, GCLPs), Good Clinical and Pharmacovigilence Practices (GCPs, GPVs), Good Manufacturing Practices (clinical supplies and commercial product - GMPs) and Good Distribution Practices (GDPs). The enterprise QMS will govern the GxP regulated work performed by ~7,000+ employees across R&D and GPS and associated interfaces with other divisional and enabling functions. Critical to this role will be to understand internal and external needs and best practices on design and operation of an enterprise-wide QMS in order to ensure its overall effectiveness and efficiency. Manages a team of 10 to 20 professional staff inclusive of a departmental budget. This role has ultimate accountability in BMS for assuring that the content of the quality system meets global regulatory standards in these designated regulated areas.
Role Specifics
1. In strong collaboration with R&D and GPS, lead the design and integration of an enterprise-wide QMS across the product lifecycle. Responsible and accountable for the Quality System framework across GxP ensuring compliance to global regulatory requirements and regulations.
2. Serve as the business lead for the Company level Quality Standards Committee supporting the new integrated governance model for the QMS. Sets committee agendas, issues meeting summary and manages actions to completion. Works collaboratively across the GxP governance councils (spanning multiple divisions) to establish clear connections and visibility to QMS documentation framework to ensure standards are being prioritized, managed and implemented based on quality and compliance needs and requirements across the enterprise.
3. Develop and maintain the overall documentation hierarchy supporting regulated activities across GxP and the enterprise-wide QMS. This may include authoring, revisions, approvals and implementation of new or revised policies, directives and procedures and their obsolescence.
4. May serve as the business owner for IT related platforms associated with document management systems. Identify business needs to improved IT automation and innovation as needed.
5. Participate as needed in regulatory advocacy activities related to area of functional expertise.
6. Participate in the development, implementation and monitoring of QMS metrics associated with documentation system health (e.g. 3 year periodic review, CAPA on time).
7. Creates, communicates, and supports commitment to quality and compliance standards. Recommends quality improvements and manages actions to their conclusion.
8. Motivates employees and facilitates employee development. Develops remedial action for staff whose performance does not meet standards. Identifies Global
Quality Systems resources to support Quality System Framework and Learning Management
9. Sets training strategy and ensures its effective implementation to support the integrated Quality System Framework.
10. Defines departmental budget requirements and achieves budget objectives for the year.
11. Ensure awareness of evolving regulations and trends and implements systems to address potential GxP compliance impact.
12. Active participation in pharmaceutical industry meetings, symposia, workshops to establish industry relationships, best practices and regulatory guidance.
Qualifications
* A bachelor’s degree or higher and experience is required; Master's Degree with 15 plus years’ experience in pharmaceutical industry in Research and Development, Manufacturing and/or Quality.
* Strong working knowledge of GxPs in the pharmaceutical arena with a concentrated focus on US and EU across R&D and Commercial Operations.
* Strong knowledge of the drug development and commercialization process
* Demonstrated change execution and enterprise mindset skills.
* Demonstrates innovation, flexibility, open-mindedness, and adaptability in order to meet objectives in a rapidly changing environment with shifting priorities
* Demonstrated ability to influence and manage the expectations in a matrixed environment
* Demonstrated ability to use structured problem solving and available tools to quickly evaluate problems, identify root cause, create action plans, assess impact and develop resolution options.
* Excellent teamwork and interpersonal skills, with the ability to communicate and collaborate with employees and management at all levels.
* Able to complete multiple, simultaneous projects with minimal supervision and prioritize incoming work appropriately
* Demonstrated ability to work with a range of technically, culturally & geographically diverse teams in a matrixed environment, influencing them to complete deliverables, and delivering value added business results that meet high quality requirements within tight deadlines
* Demonstrated ability to effectively communicate to a diverse audience at multiple levels within the company through various formats, such as presentations, written proposals, reports, correspondence, leading meetings, face-to-face dialogue etc.
