J&J Family of Companies Janssen Quality Associate (Compliance) in Sydney, Australia

  • Located at North Ryde

  • Exciting opportunity to be part of a global brand

  • Dynamic and challenging role

Be Vital in this role

An exciting opportunity has arisen to join Janssen in a Quality Assurance role. Reporting into the Quality Assurance Manager, this critical role will provide effective quality support to Janssen business partners and key stakeholders to ensure our products are managed with a high focus on Quality and Compliance, to meet the expectations of customers and patients while meeting J&J, ISO and regulatory standards.

You will be part of the Business Quality organization for Pharmaceuticals within Janssen ANZ.

Key responsibilities will include:

  • Provide support for the implementation and improvement of Quality Management Systems

  • Provide Quality support and approval of NCR’s, CAPA’s and Change Controls

  • Provide Quality input for the development and review of documents

  • Ensure J&J standards are effectively implemented, and support on-going compliance

  • Support continuous improvement initiatives through active project participation

  • Supplier Management including establishing and maintaining Quality Agreements

  • Provide oversight for planning and approval to ensure products supplied meet requirements as per the licenses

  • Conduct internal and supplier audits, actively support regulatory, corporate and other third party audits.

  • Ensure launch dates are achieved without Quality delays for new products

  • Enable Business Units in process improvement, systems support and compliance gap remediation

  • Facilitate the collection of Quality metrics and ensure input into the reporting systems

Qualifications

Be Valued for who you are

We are looking for a candidate with an inquisitive nature to challenge the status quo and bring innovative ideas to the team.

This role involves extensive partnering and liaison with key internal and external stakeholders. Excellent communication skills with a high emotional intelligence is required to interact with and influence stakeholders.

The ideal candidate will possess the ability to work in a dynamic and ever changing environment with the skills to navigate through complexity and change.

A minimum of 2 years’ experience is required in Quality Assurance within the Pharmaceutical or Medical Device industry. The role holder will have scientific tertiary education with an understanding of of quality systems, health authority regulations and quality standards e.g. ISO 9001, ISO 13485.

Be part of something bigger than yourself

At Janssen, we believe there are no limits to what science can do. In our search for the solutions to the medical challenges of our time, we have consistently invested 11 per cent of our global sales in research and development. We have a strong record in discovering new treatments and making them available to patients. In 2012 the InnoThink Center for Research recognized Janssen’s world-class discovery and development achievements and named us the Most Productive Pharmaceutical Company

If you are interested in progressing your career into this type of role and have the experience outlined above, please apply online using the link below. You will receive an automated email confirming receipt of your application. Should you have any further questions regarding the role, please contact Lisa Arthur in the Johnson & Johnson Talent Acquisition team on 02 9815 3171. Every application is reviewed by the Talent Acquisition team and candidates will receive notification of the outcome of their application in a timely manner.

Agencies please note: this recruitment assignment is being managed directly by Johnson & Johnson’s Talent Acquisition team. We will reach out to our preferred agency partners in the rare instance we require additional talent options. Your respect for this process is appreciated.

Primary Location

Australia-New South Wales-Sydney

Organization

Janssen-Cilag Pty Ltd (7490)

Job Function

Quality Assurance

Requisition ID

1700174204W