QA Manager II
About The Position
Iatric Manufacturing is seeking an experienced and strategic Quality Assurance Manager II to lead our Quality Assurance, Quality Control, and Quality Engineering teams in an FDA-regulated manufacturing environment. This role is ideal for a quality leader who is passionate about continuous improvement, regulatory compliance, product safety, and developing high-performing teams. As a member of the site leadership team, you will partner with Operations, Engineering, Product Development, and Global Quality teams to drive quality initiatives, improve manufacturing performance, ensure regulatory compliance, and support business growth.
Requirements
- Bachelor's degree in Science, Engineering, or a related technical discipline.
- 10+ years of Quality Assurance leadership experience within an FDA-regulated manufacturing environment.
- Experience managing Quality Assurance, Quality Control, and Quality Engineering functions.
- Strong working knowledge of FDA regulations (21 CFR Parts 11, 210, 211, and 820)
- Strong working knowledge of cGMP manufacturing environments
- Strong working knowledge of ISO 13485
- Strong working knowledge of CAPA, Root Cause Analysis, and Risk Management
- Strong working knowledge of Process, Cleaning, Software, and Analytical Method Validation
- Strong working knowledge of Statistical Process Control and Lean Manufacturing principles.
Nice To Haves
- Pharmaceutical and/or Medical Device manufacturing experience.
- Professional certifications such as Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), Certified Pharmaceutical Professional (CPP), or Regulatory Affairs certifications.
Responsibilities
- Lead all Quality Assurance, Quality Control, and Quality Engineering activities.
- Oversee investigations, deviations, nonconforming materials, CAPA, and quality system activities.
- Drive continuous improvement initiatives focused on quality, efficiency, and compliance.
- Ensure compliance with FDA regulations, cGMP requirements, and quality management systems.
- Lead internal and external audits and support regulatory inspections.
- Collaborate with customers, suppliers, and cross-functional teams on quality-related matters.
- Support new product introductions, process validation activities, and risk management initiatives.
- Develop, mentor, and coach quality professionals while fostering a culture of accountability and excellence.
- Lead site quality reviews, strategic planning efforts, and management review activities.
Benefits
- Opportunity to influence site strategy
- Opportunity to build high-performing teams
- Opportunity to help manufacture products that meet the highest standards of quality and safety
- Collaborative environment
- Continuous improvement is valued
- Innovation is valued
- Professional growth is valued
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What This Job Offers
Job Type
Full-time
Career Level
Senior
