Thermo Fisher Scientific Sr. Director, Global Quality Management Systems in Waltham, Massachusetts
The Sr. Director leads the continuous development, deployment, and improvement of the global Quality Management System (QMS) that ensures a high state of cGMP compliance and supports the effective execution of PSG objectives.
Reporting to the Sr. Director, Global Quality Systems, the Sr. Director Quality Management Systems will be a member of the Extended Quality Leadership Team (ExQLT) and partner across PSG to achieve strategic quality objectives. This leader will embed Practical Process Improvement (PPI) across the organization to ensure harmonization, simplification, and efficiency. They will watch key performance metrics and partner to drive improvement. The position will work closely with PSGs manufacturing sites worldwide to ensure alignment and execution of the Quality Management System.
Develop, establish, improve, and maintain the global QMS elements, including policies, processes, procedures, and controls, enabling successful and efficient development and manufacturing of pharmaceutical products meeting customer and regulatory requirements.
Establish PSG QMS team goals and objectives for the group; cascade these objectives to team members.
Interact with quality and site management on the performance of quality systems.
Lead the Quality Management Review process, ensuring all sites, business units and divisions report performance and system health to be included in the group level QMR which is led by you.
Responsible for the global electronic document management (eDMS) team for PSG, ensuring effective and efficient document management. Lead improvements to adoption of global document practices; develop real-time dashboards to gauge quality systems health.
Develop a robust system to assure corrective and preventive measures are systematically implemented and controlled.
Improve the efficiency of QMS leading simplification initiatives throughout the organization.
Develop relationships with professional organizations and practitioners to stay abreast with current Best Practices relevant to QMS.
Maintain current knowledge of national and regional regulations regarding QSR, ISO, MDD, and quality assurance issues as they impact PSG QMS.
How will you make an impact:
You will lead the direction for QMS to ensure our sites are able to deliver on the mission and set up for success.
What will you do:
Establish and maintain risk-based, fit-for-purpose Quality Management System (QMS) for PSG. Develop, communicate, and ensure implementation of Quality Manual, Quality policies, standards, global procedures and processes across the PSG network.
Interact internally and externally with quality and site management to report on the performance of the quality system.
Lead the Quality Management Systems Team, insuring individual and team goals are set, and performance objectives are established for individuals to meet their professional growth aspirations.
Establish robust, comprehensive systems to assure corrective and preventive measures are implemented and controlled.
Direct core Subject Matter Experts (SMEs) in New Product Introduction, Validation, Change Control, and Deviation Management to ensure current industry and regulatory perspectives are included in our systems.
Lead the Communities of Practice effort to ensure all quality systems have a global owner who engages with SMEs throughout PSG.
Create on-going, robust systems to improve, simplify, and increase efficiency of PSG’s QMS.
Provide leadership, vision, and direction to the Global Quality Organization to create best in class Quality systems, enabling PSG to meet or exceed our customers’ expectations.
Lead the development and drive implementation of the PSG QMS strategy in collaboration with peers and partners, ensuring alignment with the broader Quality and PSG strategy.
Ensure proper governance and oversight of Quality systems and processes. Establish Quality council framework and handle customer issues including “Notice of Significant Events”, recalls, field alerts etc.
Lead Quality integration efforts to ensure new or acquired sites are rapidly integrated and on-boarded to the PSG QMS.
B.S. Degree in business or a scientific/technical field required. Advanced degree such as MBA or master’s desired.
Minimum of 15 years’ experience in multinational pharma/biopharma organizations, covering multi-site quality systems, and quality operations roles with global experience.
Broad knowledge and experience with quality assurance and quality system, quality operations, regulatory compliance and understanding of current international regulatory requirements and trends for the manufacturing of API, DS and DP and advance therapies.
Ability to solve organizational problems across boundaries, geographic regions, cultures, and business units to ensure standardized application of quality system practices.
Demonstrated leadership across functions and organizational levels.
Experience in strategy development and deployment, organisational change, and business improvement.
Strong people leader to engage and motivate a team of professionals.
Embodies our Thermo Fisher values of Integrity, Involvement, Intensity, and Innovation.
Demonstrate the ability to incorporate sound risk management fundamentals in the establishment of QMS
Demonstrates excellent interpersonal verbal and written communication.
Ability to travel frequently, including internationally (25 - 40%) - dependent on business needs.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one distributed team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
All U.S. colleagues are required to disclose vaccination status. New hires will be asked to disclose vaccination status upon the first day of employment.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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