Job Description
We are seeking a seasoned Quality Systems Leader to build, standardize, and stabilize quality operations across both a manufacturing site and its supporting laboratory environment. This is a transformation-focused leadership role, ideal for someone who has successfully implemented quality systems from the ground up and driven measurable operational improvement.
This is not a maintenance role—the site is evolving from a startup environment into a more mature, scalable operation and requires a leader who can establish structure, drive change, and elevate overall quality performance.
Key Responsibilities
Quality Systems & Governance
Design, implement, and standardize end-to-end Quality Management Systems (QMS) aligned to ISO standards
Establish structured processes across manufacturing and laboratory functions, ensuring consistency and scalability
Lead efforts to prepare the site for ISO certification and external audit readiness
Validation & Compliance
Own and oversee all validation activities, including:
IQ/OQ/PQ
Process validation
Cleaning validation
Software/systems validation
Strengthen validation rigor and ensure compliance with regulated environments (FDA, chemical industry standards)
Operational Excellence & Continuous Improvement
Drive Lean Quality and Continuous Improvement (CI) initiatives to reduce waste, improve cycle times, and optimize working capital
Improve:
Test analysis timelines
Product qualification processes
Validation efficiency
Introduce structured problem-solving methodologies (e.g., root cause analysis, data-driven decision-making)
Problem Solving & Quality Performance
Lead and facilitate root cause investigations, CAPAs, and change control processes
Address ongoing quality issues through data-driven diagnostics and corrective actions
Improve overall process reliability, repeatability, and performance
Laboratory Leadership
Oversee laboratory operations, including staffing, workflows, and process efficiency
Assess current capabilities and implement improvements to increase throughput and reduce turnaround times
Align lab operations with broader quality and manufacturing objectives
Cross-Functional Partnership
Partner closely with Manufacturing to improve process stability and product quality
Benchmark sister sites and implement best practices and standardized processes locally
Serve as the site-wide quality leader, influencing stakeholders at all levels
Coaching & Change Leadership
Build a continuous improvement mindset across the workforce
Coach and upskill teams on:
Structured problem-solving
Data analysis and interpretation
Quality best practices
Lead organizational change as the site transitions to a more mature operating model
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
-8+ years of experience in Quality Systems, Quality Engineering, or Quality Leadership roles within manufacturing environments
-Hands-on experience preparing sites for and supporting ISO certification and external audits
- Experience designing and implementing processes/systems
- Exposure to regulated environments (FDA, chemical industry)
- Strong FMEA and problem‑solving experience
- Experience with ISO 9001 and/or ISO 14001
- Comfortable communicating up and down the organization
-Hands‑on, systems‑focused, and able to drive change
Nice to Have Skills & Experience
• 13485 experience
• Auditing experience
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.