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!
Our excellent reputation has been built on tailoring solutions and services to each of our clients, to ensure that their expectations are surpassed, and all their requirements are exceeded.
We are seeking a seasoned Senior Director of Quality Assurance with over 15 years of experience to lead a transformative quality initiative for our client, starting with sites in the Northeastern U.S.
The ideal candidate will possess extensive expertise in GMP and a proven track record in manufacturing environments within the pharmaceutical or CMO sectors.
This role demands a dynamic leader who can drive rapid change, spearhead the implementation of a new QMS, and support critical remediation efforts.
Compensation: Competitive basic salary + Benefits including healthcare, 401K, paid sabbatical.
The Role
Responsibilities include:
- Leading and managing comprehensive quality remediation efforts, addressing numerous existing issues while ensuring timely resolution of new concerns as they arise.
- Overseeing the deployment of a modern, compliant QMS, managing core quality processes including deviations, investigations, change controls, and CAPA.
- Collaborating with project leadership to drive quality improvements across U.S. sites, with the potential for international expansion.
- Managing inspections, audits, and regulatory engagements, ensuring compliance with FDA requirements and minimizing the risk of warning letters.
- Fostering a quality and continuous improvement culture, working with leadership to promote data integrity and modern quality practices.
Requirements
- 15+ years of experience in Quality Assurance with deep knowledge of GMP in the pharmaceutical or CMO industries.
- Proven success in leading large-scale quality transformations in a manufacturing setting.
- Expertise in managing complex remediation efforts and navigating quality processes such as deviations and root cause analysis.
- Strong leadership capabilities, particularly in overcoming resistance and facilitating cultural change within established organizations.
- Ability to collaborate with senior leadership to execute quality initiatives under tight deadlines.
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.