Senior Manager, QMS Governance, Continuous Improvement

Job Description: • Support quality initiatives that deliver consistent product excellence while meeting business objectives • Develop quality professionals, lead investigations, and implement data-driven solutions that enhance quality systems and customer satisfaction • Guide strategic quality initiatives and support a culture of continuous improvement • Oversee quality management systems and ensure regulatory compliance • Enhance customer experience through excellent quality standards • Collaborate with cross-functional teams to develop and implement quality strategies • Manage quality assurance and quality control teams • Build strong partnerships with operations, R&D, and commercial teams • Guide process improvements through Practical Process Improvement (PPI) methodologies and risk-based approaches • Maintain inspection readiness, manage customer relationships, and ensure compliance with global regulatory requirements Requirements: • Advanced Degree plus 6 years of experience, or bachelor’s degree plus 8 years of experience in pharmaceutical, medical device, or regulated life sciences industry • Preferred Fields of Study: Science, Engineering, Chemistry, or related technical field • Professional certifications desired (ASQ, Lean Six Sigma, etc.) • 5+ years of quality management/leadership experience • Expert knowledge of global quality standards (ISO 13485, ISO 9001, FDA 21 CFR 820, EU MDR/IVDR) • Strong understanding of quality management systems and GMP requirements • Demonstrated experience leading quality investigations, CAPA, and change control processes • Experience implementing continuous improvement initiatives • Experience with quality tools including FMEA, Risk Analysis, and Root Cause Analysis • Excellent project management and cross-functional leadership abilities • Strong data analysis and problem-solving capabilities • Excellent written and verbal communication skills • Ability to build collaborative relationships at all levels • Experience hosting regulatory inspections and customer audits • Proficiency with quality management software systems • Ability to travel up to 25% Benefits: • Medical, Dental, & Vision benefits-effective Day 1 • Paid Time Off & Holidays • 401K Company Match up to 6% • Tuition Reimbursement – eligible after 90 days! • Employee Referral Bonus • Employee Discount Program • Recognition Program • Charitable Gift Matching • Company Paid Parental Leave • Career Advancement Opportunities Apply Now Apply Now