Quality and Compliance Lead (10-Month Parental Leave Cover)

The Opportunity

We have an exciting opportunity for a Quality and Compliance Lead to join our Medicine division on a 10‑month parental leave contract, based in Sydney, NSW and reporting to the Head of Quality Medicine.

This role offers the opportunity to play a critical role in driving Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GvP), while strengthening quality governance across the product lifecycle to ensure patient safety and data integrity.

You will work at the intersection of quality systems and regulatory compliance, partnering closely with cross‑functional stakeholders to identify, assess, and mitigate risks and drive continuous improvement.

As the Quality and Compliance expert for the organisation, you will champion a quality mindset, inspection readiness, and accountability — helping ensure the business meet both global standards and local regulatory expectations.

Key Responsibilities

• Develop, maintain, and continuously improve the Global Quality Management System (QMS), ensuring appropriate tailoring to the (R)OPU in line with local regulatory requirements.


• Assess the impact of Regulatory Intelligence Network (RIN) updates on Quality and Compliance processes, acting on and escalating topics as required.


• Lead the implementation and maintenance of global procedures in a pragmatic, clear and concise way and ensure adherence to the local regulatory and business requirements.


• Lead inspections end‑to‑end, representing the BI compliance position during regulatory inspections and ensuring timely and robust responses to findings.


• Contribute to audit ensuring audit observations are appropriately investigated and actions are effectively implemented, and ensure that lessons learnt are implemented.


• Define quality and compliance service requirements in collaboration with the Medicine function.


• Provide quality trending, analysis, and optimisation insights across Medicine functions.


• Act as subject matter expert for Non‑Compliance and Issue Management, including root cause analysis and CAPA development.

Your profile

• Bachelor’s degree in Science, Life Sciences, Biomedical Sciences, Pharmacy, or related discipline.


• Clinical research industry or equivalent experience and good knowledge of international guidelines (e.g.: Good Clinical / Pharmacovigilance Practices)


• Effective communication and stakeholder‑engagement skills.


• Ability to work independently while contributing effectively within a team.

What’s next? - How to apply

If you would like to be part of this highly driven and successful team, please submit your CV addressing the key criteria above.

You must have the right to live and work in this location to be considered for this opportunity.

It is our policy not to accept speculative resumes from recruitment agencies.

Position Area

Human Pharma

Position Location

NSW

Organization

Boehringer Ingelheim

Schedule

Full-Time

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