Sr. Project Manager – Qms

Sr. Project Manager – Qms

Requirements

• Bachelor’s degree in engineering, science, or a related field.
• Minimum 11 years experience in project management, with a significant focus on quality management system implementation or harmonization projects.
• Strong and in-depth knowledge of global medical device quality management system requirements, including ISO 13485, FDA 21 CFR Part 820, and other relevant regulations.
• Proven experience in analyzing, designing, and implementing harmonized QMS processes and procedures across multiple sites.
• Experience in leading cross-functional teams and managing stakeholders in a global environment.
• Demonstrated ability to develop and manage detailed project plans, including scope definition, timelines, budgets, and resource allocation.
• Excellent communication, presentation, and interpersonal skills, with the ability to influence and build consensus at all levels of the organization.
• Strong problem-solving and analytical skills, with the ability to identify root causes and implement effective solutions.
• Ability to work independently and manage multiple priorities in a fast-paced environment.

Responsibilities

• Lead and manage the global QMS harmonization project from initiation to closure, ensuring adherence to timelines, budget, and quality objectives.
• Develop a comprehensive project plan outlining the scope of harmonization, key milestones, resource requirements, and risk mitigation strategies.
• Facilitate cross-functional workshops and meetings to analyze existing QMS frameworks across different sites and identify areas for harmonization and standardization.
• Define and document a unified global QMS framework that aligns with applicable regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, ISO 9001) and best practices.
• Oversee the development and implementation of standardized QMS processes, procedures, and documentation across all relevant sites.
• Manage the integration of various QMS elements, including document control, change control, CAPA, internal audits, training, and supplier management, into a cohesive global system.
• Identify and analyze gaps between current state QMS and the target harmonized framework and develop effective remediation plans.
• Lead the development and execution of a comprehensive communication and change management plan to ensure stakeholder buy-in and successful adoption of the harmonized QMS.
• Manage and track project progress, providing regular updates to stakeholders on key milestones, risks, and challenges.
• Identify, assess, and mitigate project risks and issues related to QMS harmonization, developing contingency plans as needed.
• Collaborate with IT and other relevant departments to ensure the appropriate technology and systems are in place to support the harmonized QMS.
• Support internal and external audits related to the QMS harmonization project and ensure timely resolution of any findings.
• Monitor the effectiveness of the harmonized QMS post-implementation and drive continuous improvement initiatives.

Preferred Qualifications

• Experience with implementing and integrating QMS software solutions.
• Familiarity with change management methodologies and tools.
• Experience with risk management methodologies and their application within a QMS context.
• Knowledge of Lean or Six Sigma principles and their application to quality system optimization.
• Experience in managing projects involving the integration of quality management systems with other business systems (e.g., ERP, PLM).
• Proven track record of successfully navigating complex organizational structures and cultural differences in global projects.
• Project Management Professional (PMP) certification or equivalent.
• Experience with audit management processes and software.