Senior Quality Assurance Manager

The Sr. Quality Manager is responsible for leading the development, implementation, and continuous improvement of quality systems and overseeing quality assurance and control across an organization, ensuring all products meet stringent safety, regulatory, and customer requirements while driving operational excellence and a culture of quality across the organization. This role is a critical leadership position responsible not only for managing quality, but for building and scaling the quality function from early-stage ramp through full production in a high-growth environment. Strategic Quality Oversight: Own and drive implementation of the long-term vision for building and scaling the quality organization, systems, and talent capable of supporting rapid production ramp, process changes, and product evolution. Ensure systems are structured to support data-driven decision-making and real-time performance visibility. Develop, implement, and maintain Management System and quality programs to meet internal and external standards including ISO and industry-specific regulations (e.g., ISO 9001, IATF 16949, ISO14001). Lead, mentor, and train staff on quality standards, best practices, and quality control procedures. Foster a culture of accountability, continuous improvement, and operational excellence across departments. Process and Product Quality Management: Drive enterprise-level quality initiatives across Engineering, Operations, and Supply Chain to ensure alignment on product and process excellence. Monitor production processes, conduct inspections, and ensure products meet quality and efficiency standards. Apply statistical process control (SPC) and other analytical methods to evaluate processes and identify areas for improvement. Drive quality assurance across all stages: incoming materials, in-process production, and final product testing. Implement advanced quality tools (e.g., Six Sigma, SPC, FMEA, root cause analysis). Lead efforts to reduce defects, scrap, and rework while improving yield and reliability. Partner closely with Engineering to influence Design for Manufacturability (DFM) and Design for Quality (DFQ) initiatives. Support the transition of new products and processes from development into production, ensuring robust quality validation and control plans. Operate effectively in non-steady-state manufacturing environments, managing variability,process instability, and yield challenges. Oversee the analytical laboratory and functions, processes, and operations including equipment and chemical management Customer & Supplier Quality: Act as the primary quality liaison with customers, addressing complaints, audits, and corrective actions Oversee supplier quality management, including qualification, audits, and performance monitoring. Ensure timely resolution of non-conformances and implementation of corrective/preventive actions (CAPA). Lead customer qualification efforts and ongoing quality performance for high-reliability end markets. Establish rigorous supplier development and quality assurance processes to support advanced materials and critical components. Auditing, Compliance and Reporting Lead internal and external audits, prepare for ISO certifications, including customer and regulatory inspections. Investigate customer complaints, perform root cause analysis, and implement corrective and preventive actions (CAPA). Gather and analyze quality data, identify trends and improvements and prepare reports for senior management to support decision-making and strategic planning Implement advanced analytics, real-time dashboards, and statistical tools to enable predictive quality and performance optimization. Drive cost-of-quality reduction initiatives while supporting aggressive production and scaling targets. Education & Experience Requirements: Bachelor's degree in Quality Management, Engineering, Business Administration, or related field 10+ years of experience in quality assurance within manufacturing environments; experience in battery, electronics, chemical, or automotive industries strongly preferred; familiarity with regulatory standards and compliance requirements. Experience in battery manufacturing, electronics, chemical processing, automotive, energy storage, or other highly regulated industries strongly preferred. Demonstrated experience developing and implementing quality systems, driving continuous improvement initiatives, and leading cross-functional teams. Strong knowledge of regulatory compliance requirements, manufacturing quality standards, and customer quality expectations. Certifications & Technical Qualifications: Certified Quality Manager (CQM) or equivalent, preferred; Experience with ISO 9001, IATF 16949, or other relevant management systems, required Knowledge of Six Sigma or Lean methodologies, preferred Experience operating in complex, technically advanced manufacturing processes with high variability, preferred Skills & Competencies: Strong analytical, critical thinking, and problem-solving skills with the ability to identify root causes and implement corrective actions. Proven leadership capabilities with experience managing and mentoring quality teams and influencing cross-functional stakeholders. Advanced knowledge of statistical process control (SPC), quality control methodologies, CAPA processes, FMEA, and continuous improvement techniques. Proficiency with quality management systems (QMS), inspection tools, manufacturing software, and data analysis platforms. Excellent verbal and written communication skills with the ability to present findings and recommendations to all levels of the organization. Strong project management and budget management experience. Ability to balance strategic quality initiatives with day-to-day operational demands. Strong organizational skills with the ability to prioritize multiple projects in a fast-paced manufacturing environment. Physical Requirements & Working Conditions: This position operates primarily in a manufacturing and production environment and requires the ability to: Lift and carry up to 50 pounds occasionally. Sit, stand, walk, bend, kneel, and squat for extended periods of time, including periods exceeding four hours. Wear appropriate personal protective equipment (PPE) and obtain medical clearance to wear a respirator. Work within industrial manufacturing environments that may include varying temperatures, noise levels, and production floor conditions. Travel up to 25% to support suppliers, customers, audits, and company facilities. Provide support for critical manufacturing operations during evenings, weekends, holidays, or outside normal business hours when necessary. #J-18808-Ljbffr United Pharma