Change Management Director/Senior Director of Quality Assurance
G&L Healthcare Advisors is a specialist provider to the healthcare industry for all types of Quality Assurance and Regulatory Affairs consultancy work – and we are rapidly growing!
We are looking for a dynamic Change Management Director/Senior Director with 10-15 years of experience to lead a comprehensive quality transformation for our client.
The ideal candidate will be an experienced change agent with a strong background in modernizing Quality Management Systems (QMS) within the pharmaceutical or Contract Manufacturing Organization (CMO) sectors.
This role requires expertise in GMP, strong leadership capabilities, and the ability to drive cultural change as the client transitions from outdated 1990s-era quality practices.
Compensation: Competitive basic salary + Benefits including healthcare, 401K, paid sabbatical
The Role
Responsibilities include:
- Leading the complete overhaul of the client’s QMS, ensuring alignment with modern regulatory standards and robust data integrity practices.
- Implementing change management initiatives to modernize quality processes and eliminate outdated practices.
- Collaborating with cross-functional teams to establish and maintain key quality processes, including deviations, change controls, CAPA, and LIR systems.
- Driving quality improvement efforts at the client's Northeastern U.S. sites, with plans for future international expansion.
- Serving as a strategic partner to the project lead, offering guidance and operational support to elevate overall quality standards.
- Developing and executing a change management strategy that aligns the organization with a culture of quality and continuous improvement.
- Overseeing and ensuring the timely execution of remediation efforts, maintaining clear communication with stakeholders.
Requirements
- 10-15 years of experience in Quality Assurance, transformation, and change management within the pharmaceutical or CMO industries.
- Strong expertise in GMP compliance and leading quality transformations in manufacturing/plant environments.
- Proven track record in driving large-scale quality change initiatives, particularly within organizations with long-standing cultural practices.
- Ability to manage complex projects with urgency, particularly in high-stakes environments facing FDA inspection risks.
- Excellent leadership, communication, and influencing skills, with the ability to engage senior leaders and operational teams.
How to Apply
For further details, please send your CV to: talent@gandlhealth.com
Why Join Us?
- Opportunity to work on cutting-edge QA projects across diverse fields.
- Collaborative and innovative environment with opportunities for professional growth.
- Competitive salary and benefits package.
If you are a highly skilled and versatile QA professional looking for an exciting role with diverse challenges, we would love to hear from you!
G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status, or race.
We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.
G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment, and abuse.
All employees at G&L share the responsibility to challenge discriminatory behavior and promote equality of opportunity.