Associate Director, Quality Assurance

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Job Description Lead end-to-end quality and compliance for a critical manufacturing site, ensuring the highest standards of safety, efficacy, and regulatory excellence while enabling reliable supply to the market. Shape site strategy as a key member of the leadership team, driving continuous improvement, operational excellence, and cross-functional alignment across quality, supply, and commercial priorities. Build and lead high-performing quality teams while partnering with global stakeholders and regulatory bodies to deliver compliant, innovative, and patient-focused outcomes. Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. What will you do: The primary responsibility of the Site Quality Head is to lead quality operations and have overall responsibility for the product quality and compliance status of the Upper Hutt Animal Health Site. Responsible for ensuring policies, systems, processes and practices are implemented and maintained at the site which ensures products are manufactured, packaged and marketed in accordance with current standards for Quality, Efficacy, Safety, Potency, and Purity. Provide management support to all staff within the Quality Functions of the site. Partner with Global Supply Chain colleagues in focusing the site on alignment and attainment of scorecard-based objectives, including those related to People, Safety, Quality, Delivery and Cost. Provide quality support and partner with commercial functions to support local animal health business objectives. Provide strategic direction and support for both the quality function and operations, playing an integral part in strategic decision making as a key member of the site leadership team. Serve as primary contact with government regulatory agencies during market actions, and as required. Liaison with internal Regulatory Affairs to ensure alignment in achieving this. Direct any recall and stop sales activities, providing summaries internally and to regulators as required. Ensure the site is prepared for regulatory inspections. Host inspections and coordinate the responses to regulatory inspections or inquiries, and work proactively to maintain compliant and timely communications to regulators as required. Responsible for site Quality budget. The Site Quality Manager sits within the Global Quality organization and reports to the APAC Regional Quality Lead. Leadership and Strategy - Be part of a developing High Performing Site Leadership Team through: Developing / adapting site strategy to identify and prioritize key site projects and KPI's and track performance in tier 5. Sponsor site strategic workstreams and own translation of workstream strategy to specific site and IPT targets and projects. Continuous reflection with the Site Leadership Team to improve collaboration and Ways of Working and actively sponsor and participate in activities that build on a sense of belonging across the site. On the Job Development of your managers and teams through: Lead and manage a team of Quality managers and specialists providing guidance, training, and performance evaluations. Continuously improving and coaching of Tier 2 and Tier 4 to prioritize key activities and ensuring alignment, effective information flow and accountability between & within areas. Routine 1:1's and daily coaching Gemba's to continuously improve Management Systems and Ways of Working and actively manage Succession Planning. Embed a culture of continuous improvement by empowering teams to solve problems at the right level leveraging MPS adoption. Promoting a strong safety and compliance culture through sponsorship and daily Gemba's. Support Daily Management activities through: Effective management systems that align make-test-release schedules across the site and ensures problems or opportunities in related areas (e.g. trends in antigen yields, aborted batches, testing issues, etc.) are made visible urgently and continuously improved. Effective Tier 2, Tier 3 and Gemba's to ensure operational performance meets budget/forecast expectations and our improving compliance culture meets all legal, safety, quality and financial compliance requirements. Quality and Safety System Sponsorship and Ownership to enhance EHS and Quality standards by mentoring of SSO's to establish more efficient and effective standards. Foster a culture of Continuous Improvement and Risk Based Quality mindset through: Partnering with and supporting other sites and functions as required, e.g. during regional improvement activities, during the technical transfer of products into and out of the site, or during cross site investigations. Actively improve or develop new GMP related systems an

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