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Quality Systems and Compliance Manager
Life Sciences
New York, United States
70 USD Per Hour
4 Aug 2025
Job Description
General position summary:
The Quality Systems Manager is an advanced technical resource in the principles and application of quality systems and compliance. The role coordinates or executes alignment of procedures and processes related to the Quality Management System and helps drive Quality improvements. They coordinate projects and takes a role in the design and execution of processes.
Key Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
Minimum qualifications:
Knowledge and Skills:
Education and Experience:
The Quality Systems Manager is an advanced technical resource in the principles and application of quality systems and compliance. The role coordinates or executes alignment of procedures and processes related to the Quality Management System and helps drive Quality improvements. They coordinate projects and takes a role in the design and execution of processes.
Key Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
- Responsible for supporting Quality system oversight at CDMOs, metrics, and improvement including change control, events, CAPA, escalation, and risk management.
- Generates Metrics / KPIs, Dashboards and Reports.
- Leads and/or supports the monitoring, interpretation, and communication of QMS processes and metrics requirements including remediation plans.
- Provides hands-on expertise in the day-to-day management of data collection systems and control within the GxP Quality Management System using digital solutions.
- Assists Change Control, deviation, and CAPA owners with ensuring compliance to change procedure requirements.
- Provides Project Management coordination for department projects/initiatives.
- Identifies and implements continuous improvement to improve processes and make them efficient and scalable.
Minimum qualifications:
Knowledge and Skills:
- Knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing.
- Demonstrated leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
- Experience coordinating projects and continuous improvement initiatives within stated objectives and timelines; effectively applies project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks.
- Ability to represent the Quality unit in cross-functional teams.
- Ability to communicate cross-functionally, exchange complex information, and influence others to understand a point of view and gain alignment around a proposed action.
- Demonstrated ability to work independently to provide QA advice for projects.
- Demonstrated ability to evaluate quality matters and make decisions leveraging technical experience and judgement.
- Experience with electronic document management systems (e.g., Veeva).
- Understanding of Python, PowerBI, Smartsheet, automation, integration, Veeva, Amazon Web Services (AWS), etc.
Education and Experience:
- Bachelor's degree in a scientific or allied health field (or equivalent degree).
- Typically requires 4 years of experience, or the equivalent combination of education and experience.
Skills
GxP (GMP GLP GDP)
Change Control
CAPA (Corrective & Preventive Actions)
Job Reference
165801
Date Posted
4 Aug 2025
Industry
Pharmaceuticals
Category
Quality & Validation
Role
CAPA Manager
Level
Senior-Level
Employment
Contract
Working Location
Hybrid
Salary/Rate
70 USD Per Hour
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