Description We seek a dynamic Quality Systems Manager to lead and maintain our quality management systems while ensuring compliance with cGMP standards and regulatory requirements. This role focuses on developing and implementing quality strategies that support our commitment to operational excellence and regulatory compliance. Hours: 8am-4pm can start earlier than 8am Duties and Responsibilities: Manage and oversee the implementation and maintenance of cGMP quality systems, including deviations, CAPAs, change control, document control, and training management systems. Lead investigations into non-conformances, out-of-specifications, customer complaints, and adverse events, ensuring thorough root cause analysis and effective corrective actions. Develop and maintain quality metrics and key performance indicators (KPIs) to monitor system effectiveness and drive continuous improvement initiatives. Coordinate internal and external audits, including FDA inspections, ensuring appropriate preparation, execution, and follow-up actions. Oversee the document control system, ensuring proper maintenance, review, and updates of Standard Operating Procedures (SOPs) and quality documentation. Lead the Quality Systems team, providing mentorship, training, and development opportunities while fostering a quality-minded culture. Collaborate with cross-functional teams to ensure quality systems integration across departments and alignment with business objectives. Manage supplier quality programs, including qualification, monitoring, and performance evaluation of key suppliers. Implement risk-based approaches to quality management, including risk assessments and mitigation strategies. Ensure compliance with applicable regulations, including FDA 21 CFR Parts 210/211, EPA requirements, and industry standards. Participate in management reviews and quality governance meetings, providing updates on quality metrics and system performance. Skills Quality assurance, cgmp, qms, audit, capa, change control, fda compliance, iso standards, spc, lean six sigma, iso 9001, sop, change management Top Skills Details Quality assurance,cgmp,qms,audit,capa,change control,fda compliance,iso standards,spc Additional Skills & Qualifications Lean Six Sigma: Knowledge of Lean Six Sigma methodologies for process improvement and waste reduction. ISO Standards: Familiarity with ISO 9001 and other relevant ISO standards for quality management systems. Statistical Analysis: Ability to perform statistical analysis to monitor and improve quality processes. Project Management: Skills in managing projects, including planning, execution, and monitoring. Training and Development: Experience in developing and delivering training programs related to quality systems. Supplier Quality Management: Managing and evaluating supplier quality to ensure compliance with standards. Technical Writing: Proficiency in writing technical documents, such as Standard Operating Procedures (SOPs) and quality manuals. Customer Focus: Understanding customer needs and ensuring that quality systems meet or exceed customer expectations. Problem-Solving: Strong problem-solving skills to address quality issues and implement effective solutions. Change Management: Ability to lead and manage change initiatives within the organization. Interpersonal Skills: Strong interpersonal skills to work effectively with cross-functional teams and stakeholders. Attention to Detail: High level of attention to detail to ensure accuracy and compliance in quality processes. Experience Level Entry Level Pay and Benefits The pay range for this position is $105000.00 - $130000.00 "Company offers full benefits, including comprehensive health and insurance packages, competitive bonus structure, 401k, paid time off, and opportunities for professional development." Workplace Type This is a fully onsite position in Azusa,CA. Application Deadline This position will be accepting applications until Jan 25, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.