Associate Director, Quality Assurance

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.

• Lead quality operations and assume overall responsibility for product quality and compliance status of the Upper Hutt Animal Health Site.
• Ensure policies, systems, processes and practices are implemented and maintained at the site to comply 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 to align and attain scorecard‑based objectives related to People, Safety, Quality, Delivery and Cost.
• 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, liaising 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, working proactively to maintain compliant and timely communications to regulators.
• Be responsible for the site quality budget.
• Develop and adapt site strategy to identify and prioritize key site projects and KPIs, track performance, sponsor site strategic workstreams, and translate strategy to specific site and IPT targets and projects.
• Continuously reflect with the Site Leadership Team to improve collaboration, ways of working, and actively sponsor and participate in activities that build a sense of belonging across the site.
• Lead and manage a team of Quality managers and specialists, providing guidance, training, and performance evaluations.
• Continuously improve and coach Tier 2 and Tier 4 activities, ensuring alignment, effective information flow and accountability among and within areas.
• Conduct routine 1:1s and daily Gemba coaching 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.
• Promote a strong safety and compliance culture through sponsorship and daily Gemba sessions.
• Support daily management activities through effective management systems that align make‑test‑release schedules across the site and ensure problems or opportunities are visible and continuously improved.
• Ensure Tier 2, Tier 3 and Gemba processes ensure operational performance meets budget/forecast expectations and compliance culture meets all legal, safety, quality and financial compliance requirements.
• Own quality and safety system sponsorship and ownership to enhance EHS and quality standards, mentoring SSOs to establish more efficient and effective standards.
• Foster a culture of continuous improvement and risk‑based quality mindset by partnering with and supporting other sites and functions during regional improvement activities, technical transfer, and cross‑site investigations.
• Actively improve or develop new GMP‑related systems and procedures where opportunities arise to drive continuous improvement.
• Provide clear leadership through significant investigations, including significant regulatory or quality events that require concurrence above site, to support the timely and compliant disposition of materials, components and products.
• Provide quality oversight for major site capital investments that directly impact product quality.
• Ensure the Site Quality Unit actively engages with regional and divisional objectives on Safety, Compliance, Supply, Strategy and Cost.
• Champion the development and maintenance of appropriate systems, procedures, awareness and culture to support a safe working environment for staff.
• In conjunction with the site director, ensure that the site quality organization is appropriately resourced in terms of headcount, equipment and training.
• Maintain productive partnership with Supply Chain to ensure alignment and focus on compliant supply.
• Ensure all legal requirements are met, including but not limited to Environmental Health and Safety (EHS). Identify, document, assess and control hazards and environmental aspects in accordance with EHS procedures.
• Develop EHS objectives, targets and performance indicators, establish EHS improvement projects and review progress.
• Ensure all employees receive such EHS information, instruction, training and supervision as necessary to perform their work safely and without significant risk to health or the environment.
• Compile EHS reports as required by senior management, regulatory authorities and others.
• Identify and record EHS monitoring requirements and implement appropriate monitoring.
• Ensure scheduled audits and inspections are conducted and necessary corrective actions are developed and completed.
• Ensure that all GMP documentation is in accordance with Company and relevant regulatory standards.
• Ensure that all PV activities relating to both internal local/global processes and New Zealand regulatory requirements are implemented where applicable across the Upper Hutt Quality Unit.

• Degree in Chemistry, Biology or related field.
• 10+ years of experience in a GMP regulated bioscience background.
• 5+ years of leadership experience.
• Proven technical ability, including knowledge of QMS, QC and manufacturing processes.
• Outstanding interpersonal skills, strong communication skills, conflict management and leadership.
• A strong team player with excellent communication, organisational and interpersonal skills and ability to operate in a matrix environment.
• Demonstrated continuous improvement, strategic and change management skills to define and translate high‑level strategies in operational and interpersonal expectations.
• Ability to build strong professional relationships both within the Organisation as well as with outside regulatory agencies and other third parties.
• Excellent communication, organisational and interpersonal skills.
• Current Employees apply HERE.
• Preferred skills include Agency Liaison, Business Decisions, Change Management, Computer System Validation (CSV), Decision Making, Driving Continuous Improvement, GMP Laboratory, People Leadership, Performance Qualification (PQ), Quality Auditing, Quality Control Documentation, Quality Management Standards, Quality Management Systems (QMS), Quality Operations, Quality Risk Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Inspections, Strategic Initiative, Strategic Planning, Supplier Quality Management, Supply Chain Collaboration, Training and Development.

We are an equal opportunity employer, committed to fostering an inclusive workplace.