QA Manager
Job in
Westland, Wayne County, Michigan, 48186, USA
Listed on 2026-09-14
Listing for:
Jobtailor
Full Time
position Listed on 2026-09-14
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
- Ensure the safety, quality, and compliance of products throughout manufacturing, packaging, and product release operations
- Provide quality oversight for site operations and drive regulatory compliance, continuous improvement, and operational excellence
- Partner cross-functionally with Operations, Engineering, Maintenance, Laboratory, and Quality teams to identify risks and resolve quality issues
- Lead and develop quality professionals
- Support regulatory and customer audits
- Provide risk-based decision making
- Manage technical questions from contract or retail customers and provide technical impact or risk assessments
- Promote development and succession planning for direct and indirect reports
- Lead cross-functional continuous improvement opportunities and projects
- Develop and maintain auditing and release procedures
- Develop, evaluate, and implement action plans to maintain or improve product and process quality
- Align processes with PMI and OTC objectives
- Review and approve SOP updates, change controls, and validation reports
- Lead quality-driven initiatives and continuous quality improvement
- Act as final quality approver for SWIs and SOPs
- Support FDA, customer, internal, and other regulatory audits and responses
- Typically, a minimum of 8 years in the field and 4 years supervisory experience
- University Degree or equivalent
- Bachelor's degree within related discipline required
- Six or more years’ experience in a regulated industry, pharma preferred
- Demonstrated ability in areas of people leadership and quality leadership
- Excellent written and oral communication skills
- Strong problem-solving skills and logical approach based on sound judgment and research
- Sound understanding of cGMP/FDA regulations, CFR, and FDA guidance documents related to drug manufacturing, including 21 CFR 210/211
- All application materials, including resumes and CVs, must be submitted in English
Demonstrates extensive experience in quality oversight and regulatory compliance within the pharmaceutical industry, with a strong focus on cGMP/FDA regulations and continuous improvement initiatives. Proven ability to lead teams, manage audits, and implement quality-driven processes to ensure product safety and excellence.
Highest-signal resume keywords- Quality Leadership
- Regulatory Compliance
- CGMP/FDA Regulations
- People Leadership
- Continuous Improvement
- Quality Oversight
- Risk-Based Decision Making
- Auditing Procedures
- SOP Development
- Change Control Management
- Validation Reports
- Action Plan Implementation
- Technical Impact Assessments
- Operational Excellence
- Product Quality Improvement
- Excellent Communication Skills
- Strong Problem-Solving Skills
- Logical Approach
- Sound Judgment
- Pharmaceutical Industry
- Regulated Industry
- FDA Audits
- CFR
- Quality Initiatives
- Cross-Functional Collaboration
- Succession Planning
- Manufacturing Compliance
- Product Release Operations
- Continuous Quality Improvement
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