Associate Director, Quality Assurance at Merck Sharp & Dohme Corp. /Netherlands

Upper Hutt, Wellington, New Zealand -

Full Time

Start Date

Immediate

Expiry Date

24 Sep, 26

Salary

0.0

Posted On

26 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Agency Liaison, Change Management, Computer System Validation, Driving Continuous Improvement, People Leadership, Quality Auditing, Quality Management Systems, Quality Operations, Quality Risk Management, Regulatory Affairs Compliance, Regulatory Inspections, Strategic Planning, Supplier Quality Management, Supply Chain Collaboration, Training And Development, GMP Laboratory

Industry

Pharmaceutical Manufacturing

Description

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 and procedures where opportunities arise to drive continuous improvement. Supporting and providing 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. Provides quality oversight for major site capital investments that directly impact product quality. Ensures 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, ensures that the site quality organization is appropriately resourced in terms of headcount, equipment, and training. Maintains productive partnership with Supply Chain to ensure alignment and focus on compliant supply. Ensures the Site Quality Unit engages inclusively in aligning with, and achieving, regional and divisional objectives on Safety, Compliance, Supply, Strategy and Cost. Ensure all legal requirements are met, including but not limited to Environmental Health and Safety (EHS): Ensure all hazards and environmental aspects in your area are identified, documented, assessed and controlled 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 is necessary to perform their work in a manner that is safe and without significant risk to health or the environment. Ensure all hazards and environmental aspects in your area are identified, documented, assessed and controlled in accordance with EHS procedures. 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 (for which you are responsible) 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 What should you have: Demonstrated Continuous Improvement, Strategic and Change Management skills to define and translate high level strategies in operational and interpersonal expectations. Degree in Chemistry, Biology or related field. 10+ years’ 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, including 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 Organization as well as with outside Regulatory Agencies and other third parties. We are proud to be a company that embraces the value of bringing talented and committed people together. The fastest way to breakthrough innovation is when a wide range of ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive workplace. Who we are: We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for: Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today. Required Skills: 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 Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 07/27/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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Responsibilities

Lead end-to-end quality and compliance operations for the Upper Hutt Animal Health site to ensure product safety, efficacy, and regulatory excellence. Serve as a key member of the site leadership team, managing quality teams and acting as the primary contact for government regulatory agencies.