Senior Associate - External Manufacturing Quality
We are Reckitt
Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.
Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.
Research & Development
In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
About the role
An exciting opportunity has become available for a Senior Associate - External Manufacturing Quality to join our ANZ Quality team based in Sydney.
This role will see you responsible for managing a portfolio of External Manufacturing Organisations (EMOs) across Australia and New Zealand, ensuring products are manufactured and supplied in compliance with Reckitt quality standards and applicable regulatory requirements.
This is a highly collaborative role where you will partner with internal and external stakeholders to manage quality systems, drive compliance, support audits, oversee investigations and contribute to licensing and technology transfer projects.
The role offers the opportunity to take ownership of key quality activities while providing technical leadership across external manufacturing operations.
Your responsibilities
- Manage quality relationships with assigned External Manufacturing Organisations (EMOs).
- Conduct compliance assessments and support approval activities for external manufacturers and service providers.
- Develop, review and maintain Technical and Quality Agreements.
- Support and maintain Quality Management System (QMS) processes, procedures and documentation.
- Lead investigations relating to deviations, non-conformances, complaints and CAPAs.
- Manage change control activities and quality risk assessments.
- Coordinate and review quality documentation including PQRs, stability data and technical records.
- Support supplier, internal and regulatory audits.
- Partner with Regulatory Affairs, R&D, Supply Chain, Planning and Procurement teams to deliver quality outcomes.
- Support technology transfer, product launch and licensing activities.
- Drive continuous improvement initiatives across quality systems and external manufacturing processes.
- Act as a key quality contact for manufacturing partners and cross-functional stakeholders.
The experience we're looking for
- Bachelor's Degree in Science, Chemistry, Pharmaceutical Science, Engineering or a related technical discipline.
- Minimum 5 years' experience in Quality Assurance, Quality Compliance, Quality Systems or a related quality function.
- Experience within Healthcare, Pharmaceutical, Medical Device, Consumer Health, FMCG or another regulated industry.
- Strong understanding of Quality Management Systems (QMS).
- Experience managing quality investigations, deviations, CAPAs and change controls.
- Experience working with external manufacturers, suppliers or contract manufacturing organisations is highly regarded.
- Knowledge of quality standards and regulatory requirements such as GMP, PIC/S, ISO9001, ISO22716 or similar.
- Audit experience is advantageous but not essential.
- Strong written and verbal communication skills with the ability to influence stakeholders across multiple functions.
- Ability to work autonomously while managing multiple priorities in a fast-paced environment.
The skills for success
Quality Assurance & Compliance, External Manufacturing Management, Risk Assessment & Problem Solving, Quality Management Systems (QMS), Stakeholder Engagement, Continuous Improvement, Investigation & CAPA Management, Technical Documentation, Project Management, Collaboration & Influencing, Attention to Detail, Change Management, Regulatory Compliance
What we offer
Equality
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