Job Description Summary
The purpose of this role is to provide strategic and tactical direction and oversight to ensure consistent global leadership for Management Review.
The Global Process Owner, Management Review leads a collaborative community of SMEs comprised of Segments, Regions and Functions to define, develop and implement policy, process and procedure for Management Review. The Global Process Owner, Management Review monitors internal and external regulatory observations and trends related to the process of management review process and implements changes across the enterprise to ensure compliance and drive continuous improvement.
This position will own the strategy for Management Review and also participate in other QMS tactical and strategic activities as needed. The Global Process Owner, Management Review will report directly to Director of Management Controls and is an active member of the Central Quality Team.
In accordance with all applicable federal, state and local laws/regulations and Corporate BD, procedures and guidelines, this position is responsible for:
- Owns and ensures that Management Review is effectively implemented E2E across BD
- Establish and manage a Collaborative Community for Management Review
- Establishes process to drive escalation of issues and tracks resolution through the Management Review process from site to executive leadership
- Serve as subject matter authority on Management Review
- Leads continuous process improvements and partners with Collaborative Community on key initiatives
- Defines metrics and measures to be used as part of the Management Review process with the Collaborative Community and partners with peer Global Process Owners responsible for processes reported on
- Identifies IT solutions necessary to support Management Review and works with the IT Teams to implement system solutions across BD
- Establish training requirements and orchestrate training for Management Review
- Monitors performance of Management Review and reports to senior leadership
- Monitors industry surveillance audit outcomes and takes necessary actions to align process to applicable new or revised regulatory requirements
- Monitors internal and external audit observations within BD, identifies the appropriate cause and implements fixes across the enterprise for Management Review
- Works with standards committee to monitor for external regulatory changes. Determines need for changes to policy, procedure and practices based on regulatory changes and implements where appropriate
- Benchmark trends in the industry, identify best practices and deploy at BD
- Responsible for tracking and reporting metrics and key issues that are escalated from BU/Segment Management Review to the CQRB and identifying potential issues to be reported to the Board of Directors – Quality and Regulatory Committee
- Supports regulatory inspections and audits
Supervision and Budgetary Responsibility:
- Manages project budgets and IT budgets as needed.
- Leads collaborative community (cross business/cross functional network of SMEs) which will support and drive change for Management Review
Education and Experience:
- Typically requires a minimum of a BS/MS degree in life science, engineering or other relevant discipline. Graduate degree preferred.
- At least 10 years of experience in a pharmaceutical, medical device or other regulated field (GMP mainly, GLP, GCP) with specific experience in Management Review
- Proven ability as a change agent to drive improvements across a large organization.
- Demonstrated experience establishing global Quality strategy & oversight, QMS etc., at business/manufacturing site level in a global company.
- Strong technical writing experience required.
- Excellent problem solving and analytical skills.
- Ability to develop creative approaches and solutions necessary to resolve complex problems.
- Strong communicator capable of interfacing at senior levels.
- Proven ability to work globally; ability to lead a global team and lead across cultures and regions.
- Understanding of the application of quality systems to the medical device industry.
- Ability to work effectively and influence leading decision makers across diverse areas of BD and manage complex structures.
- Articulate with ability to influence others and significantly promote and/or negotiate in situations that involve recognizing and responding to underlying concerns where others need to be persuaded to accept compromised solutions.
- Travel is required, given the global scope of the role, and would vary in intensity depending on the evolving business needs. Anticipated travel on a global basis to be around 20%.