Change Management Director

$150,000 - $150,000/Yr

G & L Healthcare LTD

Full-time - Senior

About the position

The Change Management Director will lead a comprehensive quality transformation for a client in the pharmaceutical or Contract Manufacturing Organization (CMO) sector. This role is crucial for modernizing Quality Management Systems (QMS) and driving significant cultural change within the organization. The ideal candidate will possess strong leadership skills and a proven track record in change management, particularly in environments requiring compliance with Good Manufacturing Practices (GMP).

Responsibilities

• Lead the overhaul of the client's Quality Management System (QMS) to ensure compliance with modern regulatory standards and data integrity.
• Implement change management initiatives to support a shift from outdated practices.
• Collaborate with cross-functional teams to establish and maintain quality fundamentals, including deviations, change controls, CAPA, and LIR systems.
• Drive the implementation of quality improvements at the client's sites in the northeast US, preparing for a future international rollout.
• Act as a key partner to the project lead, providing strategic guidance and operational support to elevate the client's quality standards.
• Develop a change management strategy that will engage and align the organization towards a culture of quality.
• Serve as the senior leader responsible for remediation actions, ensuring timely completion and effective communication with stakeholders.

Requirements

• 10-15 years of experience in QA, transformation, and change management within the pharmaceutical or CMO sector.
• Strong experience with GMP compliance and managing quality transformations in a plant environment.
• Demonstrated success in implementing large-scale quality change initiatives, preferably in an organization with a long-standing culture.
• Ability to manage complex projects with urgency, given the imminent FDA inspection risk.
• Excellent communication and leadership skills, with the ability to influence senior stakeholders and teams on the ground.

Nice-to-haves

• Experience in leadership roles within the pharmaceutical industry.
• Familiarity with modern regulatory standards and quality management practices.

Benefits

• Competitive salary starting from $150,000 per year.
• Full-time employment with potential for career advancement.