Quality Manager
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 Quality Manager with 5+ years of experience to support our client’s quality remediation initiatives.
The successful candidate will be instrumental in closing quality gaps, with a focus on GMP compliance, managing deviations, investigations, change controls, and ensuring data integrity.
This role will play a critical part in modernizing the client’s quality systems, beginning with sites in the Northeastern U.S.
Compensation: Competitive basic salary + Benefits including healthcare, 401K, paid sabbatical.
The Role
Responsibilities include:
- Managing and executing core quality processes, including deviations, investigations, change controls, and ensuring data integrity in compliance with GMP standards.
- Supporting the development and implementation of modern quality fundamentals, including the creation, review, and approval of master batch records and finished product releases.
- Collaborating with the Senior Director and Change Management Director to drive quality improvements and address ongoing remediation actions.
- Ensuring data integrity throughout all quality systems, partnering with cross-functional teams to integrate modern practices.
- Assisting in executing multiple remediation actions, ensuring adherence to deadlines and maintaining high-quality standards.
Requirements
- 5+ years of experience in a Quality role, preferably within the pharmaceutical or CMO sectors.
- Strong understanding of GMP, deviations, investigations, change controls, and data integrity.
- Experience with reviewing master batch records and product release is a plus.
- Proven ability to support significant quality transformations in a dynamic, fast-paced environment.
- Strong problem-solving skills, with the flexibility to adapt to changes in an evolving landscape.
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.