QA Manager

Jobtailor; Michigan; On-site; USD 120,000 - 160,000; Full time

Job summary

Jobtailor in Michigan seeks an experienced QA leader to ensure safety, quality, and regulatory compliance across manufacturing, packaging, and product release. The role requires steering cross-functional teams and driving continuous improvement in a regulated environment.

You will lead quality professionals, coordinate audits with the FDA and customers, and implement robust QA processes. Strong leadership, problem-solving, and cGMP knowledge are essential for success in this position.

Qualifications

• 8+ years in the pharmaceutical/regulated industry with 4+ years in supervisory roles
• Bachelor's degree in a related discipline; advanced degree preferred
• Demonstrated ability to lead teams and quality programs
• Excellent written and oral communication skills, with strong problem-solving abilities

Responsibilities

• Ensure safety, quality, and compliance of products throughout manufacturing, packaging, and release operations
• Provide quality oversight for site operations and drive regulatory compliance and continuous improvement
• Lead and develop quality professionals and coordinate cross-functional quality initiatives
• Support FDA and customer audits and respond with timely, robust corrective actions

Skills

Quality Leadership

Regulatory Compliance

CGMP/FDA Regulations

People Leadership

Continuous Improvement

Auditing Procedures

Risk-Based Decision Making

Education

Bachelor's degree in related discipline

University Degree or equivalent

Tools

SOP Development

Change Control Management

Auditing Procedures

Validation Reports

Job description

• 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

Requirements

• 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

Core Competencies

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

Hard Skills

• 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

Soft Skills

• Excellent Communication Skills
• Strong Problem-Solving Skills
• Logical Approach
• Sound Judgment

Industry Keywords

• Pharmaceutical Industry
• Regulated Industry
• FDA Audits
• CFR
• Quality Initiatives
• Cross-Functional Collaboration
• Succession Planning
• Manufacturing Compliance
• Product Release Operations
• Continuous Quality Improvement