Senior Quality Manager

Job Summary Provide strategic leadership for the Quality function, ensuring alignment with global, Business Unit, and regional Quality strategies. Serve as Management Representative (MR) and Person Responsible for Regulatory Compliance (PRRC), representing the site on all quality compliance matters. The role requires: Provide strategic leadership for the Quality function, ensuring alignment with Global, BU and Regional Quality strategies. Serve as Management Representative (MR) and Person Responsible for Regulatory Compliance (PRRC), representing the site on all quality compliance matters. Ensure compliance with US FDA, ISO 13485, EU MDR, MDSAP, relevant countries regulations, Business Unit and Corporate requirements. Stay up to date with evolving regulatory requirements and adjust company practices accordingly. Anticipate and prepare for evolving quality and regulatory compliance expectations, ensuring proactive audit and inspection readiness at all times. Prepare the plant for audits and inspections from regulatory authorities, ensuring readiness and compliance at all times. Lead audit response and follow up actions, maintaining a strong track record of successful inspections. Ensure QMS planning and execution, including identification, documentation, implementation, and monitoring of all required processes in alignment with quality objectives and applicable regulatory requirements. Lead and drive digital transformation of Quality function to enhance compliance, efficiency and data integrity. Lead and sustain a plant-wide Quality Culture transformation, influencing cross-functional teams to take ownership of quality and embedding accountability and continuous improvement. Serve as a key member of the Plant Leadership Team, contributing to overall site strategy with a focus on quality and fostering cross-functional collaboration. As the person accountable for the overall Quality Assurance function operation, ensure products manufactured at the plant are safe, effective, and conform to specifications, maintaining the highest standards of quality and compliance. Provide exceptional leadership, oversight and direction to the Quality function, demonstrating strong planning, decision-making, problem-solving, and team-building capabilities to drive excellence in quality operations. Supports Senior Quality Director and Direct Manager to provide essential managerial and technical expertise for strategic initiatives and critical tasks. Key Job Responsibilities Lead, develop, refine and execute the plant's quality strategy and objectives, ensuring alignment with business goals, regulatory requirements, and global quality standards. Drive comprehensive quality improvement plans, integrating risk-based thinking and measurable outcomes to enhance compliance, efficiency, and product reliability. Lead quality improvement initiatives, including complaint reduction, non-conformance reduction, and cost of poor quality (CoPQ) optimization; ensure root cause analysis and CAPA implementation are timely and effective. Foster a culture of continuous improvement, actively leading initiatives that enhance quality, operational efficiency, and organizational effectiveness; promote cross-functional collaboration to implement best practices. Champion plant-wide Quality Culture transformation, including deploying Global, BU and Regional Quality Culture programs, embedding accountability, ownership, and continuous improvement across all levels of the organization. Build and mentor a future-ready talent pipeline, developing leadership capability and succession plans within the Quality function. Represent the site in Global, BU and Regional Quality meetings, ensuring alignment, sharing best practices, and influencing enterprise-wide quality strategies. Serve as Management Representative (MR) during audits; conduct quarterly Quality Management Reviews, presenting detailed reports on the performance of the quality system and quality objectives to the leaders. Provide actionable insights and recommendations for continuous improvement. Champion regulatory readiness and inspection excellence, proactively addressing external expectations and maintaining a state of continuous audit readiness. Ensure zero critical findings by implementing predictive readiness systems, robust documentation practices, and effective response protocols. Monitor and ensure timely closure of actions, aligning site performance with Global, BU and Regional quality metrics and reporting requirements. Lead and accelerate digital transformation of the Quality function, including deployment of advanced analytics platforms to strengthen compliance and efficiency. Establish and maintain quality metrics and analytics dashboards for real-time monitoring of quality performance, predictive insights, and data-driven decision-making. Expand the scope of quality responsibilities to encompass strategic site contribution beyond routine quality operations, including digitalization, cost of poor quality (CoPQ) reduction, and talent development. Perform any other tasks as required by management. Education and Experience Requirements Bachelor's degree in Engineering, Life Sciences or a related technical discipline. Minimum of 20 years of experience in regulated industries (medical devices, pharmaceuticals or biotechnology), with at least 8 years in senior leadership roles overseeing quality systems, quality compliance and strategic initiatives. Extensive knowledge of global regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR, MDSAP etc), with a proven track record of successfully leading FDA and international regulatory inspections, consistently achieving strong compliance outcomes and zero critical findings. Certified Lean/Six Sigma Black Belt or higher, with proven experience deploying Six Sigma/Kaizen programs to drive quality and operational excellence. In-depth understanding of quality systems application in regulated industry. Industry recognized certification in a Quality System element specialty (e.g Certified Quality Manager) preferred. Proven experience in business and functional strategy, with the ability to translate global, business unit and regional quality objectives into actionable site initiatives. Demonstrated capability in setting strategic direction, aligning resources and delivering measurable results in quality and compliance. Proven ability to communicate effectively with all departments and levels of management, ensuring clear alignment and execution of quality and compliance priorities. Exceptional communication, collaboration, and influencing skills, with a proven ability to engage effectively with executive leadership, regulatory authorities, and cross-functional global teams. Must have experience in presenting to senior management and external regulators, with the ability to advocate for quality priorities while balancing business needs. Knowledge and Skills Ability to manage multiple priorities in a fast-paced, regulated environment, with a strong sense of urgency and attention to detail. Deep expertise in customer facing quality management, including complaint handling, investigation and resolution. Proven ability to lead cross-functional teams in addressing product issues, driving timely and effective corrective/ preventive actions and enhancing customer satisfaction and trust. Proven track record in leading quality improvement initiatives, including complaint and non-conformance reduction, cost of poor-quality optimization and process capability enhancement, through strategic application of data analytics for trend identification, predictive risk management and performance optimization. Strong analytical and critical thinking skills, with the ability to interpret complex data, identify trends, and drive data-informed decisions using statistical and data analytics to improve quality outcomes. Strong leadership and people development skills, with experience in building high-performing teams, coaching talent, and driving a culture of accountability and continuous improvement. Excellent communication skills (written and verbal), presentation, negotiation and stakeholder management skills, with proven ability to influence cross-functional teams and senior leadership across diverse geographies and drive alignment on complex quality initiatives. Experience in digital transformation of quality systems, including deployment of eQMS and advanced data analytics platforms/tools to enable predictive insights, strengthen compliance, and support real-time decision-making. #J-18808-Ljbffr