Senior Quality Assurance Auditor

6 days ago


Sydney, New South Wales, Australia Pharmiweb Full time
Job Title: Principal Auditor Quality Assurance

About the Role:

We are seeking a highly skilled Principal Auditor Quality Assurance to join our team at ICON. As a Principal Auditor Quality Assurance, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of innovative treatments and therapies.

Key Responsibilities:

- Leading and conducting comprehensive audits of clinical trial processes, systems, and documentation to ensure compliance with regulatory standards and guidelines.
- Collaborating with cross-functional teams to identify areas for improvement in quality assurance processes and practices.
- Developing and implementing audit plans and strategies to assess the effectiveness of quality management systems.
- Providing expert guidance and recommendations to stakeholders on quality assurance best practices and regulatory requirements.
- Contributing to the continuous improvement of quality assurance programs and initiatives.

Requirements:

- Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
- Minimum of 7 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with at least 3 years in a leadership role.
- In-depth knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).
- Strong analytical and problem-solving skills, with the ability to identify and address complex quality issues.
- Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels.

What We Offer:

At ICON, we value our employees and offer a range of benefits to support their well-being and career development. These include competitive salaries, annual leave entitlements, health insurance offerings, retirement planning, and a global employee assistance program.

Equal Opportunities:

ICON is an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment. We welcome applications from diverse candidates and are committed to creating an inclusive environment that values diversity and promotes equality.

How to Apply:

If you are a motivated and experienced professional looking to join a dynamic team, please submit your application. We look forward to hearing from you.

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