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Compliance Associate / Senior

Roche - Sydney, NSW

Manufacturing & Industrial
Source: uWorkin


At Roche, we believe it’s urgent to deliver medical solutions right now, even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are brave in both decision and action and we believe that good business means a better world. Join us in making this happen.

  • A diverse team with a supportive leader
  • Opportunity to learn and grow
  • Opportunity to make an impact for the betterment of our customers and patients

As a Compliance Associate/Senior you are passionate about promoting quality and compliance excellence within the affiliate by embedding quality principles, championing informed decision making based on assessing risk and developing partnerships throughout the organisation. 

Reporting directly to the Head of Compliance Partners, the Compliance Associate/Senior is responsible for following principle responsibilities but may not be limited to:

  • Advocates transformational thinking in compliance and quality to enable and inspire colleagues to deliver innovation faster to patients
  • Establishes, implements, trains, and conducts quality checks on standards such as controlled processes and best practices for the affiliate
  • Assists in ensuring quality, compliance and continuous audit readiness for the affiliate across all areas i.e. GxP, Compliance, Risk Management
  • Assists in ensuring that all compliance activities (GxP and non-GxP) are conducted to required standards and in accordance with SOPs, guidelines, policies, health authority regulations and ethical business standards
  • Manages the process systems and tools, process maps and approval processes that support the optimization and maintenance of affiliate processes
  • Identifies, establishes and implements systems, forums and activities to ensure that meaningful process, quality & compliance knowledge is shared across the affiliate
  • Assists in the maintenance of an overall training grid for the affiliate, including developing and implementing training programs, tools, systems, and documentation
  • Supports the Local Quality Responsible (LQR) and the maintenance of the Local Quality Management System (QMS) and its related documents, in alliance with the quality principles outlined in the Global Roche GCP/GVP Quality Manual.
  • Ensures oversight and pharmacovigilance compliance through implementation of the Global MAP process and local legislation and processes for Market Research and Patient Support Programs initiated in the affiliate.
  • Supports Legal & Ethics in compliance reporting requirements.

Who you are?

You are degree qualified within a Pharmacy/medicine/science related field with sound professional experience in the pharmaceutical/ biotechnology industry, preferably in a medical compliance function at a local, regional or global level.

You have demonstrated experience in quality management, risk management or quality control. Experience with designing and delivering training programs for GxP programs a plus.

With your excellent communication skill, strong analytical mindset and decision-making experience in a complex and changing environment, you can ensure an outstanding customer experience.

You’re someone who wants to influence your own development and looking for a company where you receive the opportunity to pursue your interests across functions. Working in a dynamic team motivates you.

What do we offer?

In return, Roche offers a competitive package, ongoing development, and opportunities for career advancement. We have an excellent range of benefits including, open plan office environment, complete with rooftop garden and complementary barista coffee. We encourage flexible working and are a moments’ walk from Wynyard Station and Barangaroo ferry terminal.

Roche encourages a high-performance culture where you are empowered and trusted to make decisions. We strive for excellence and extraordinary results and take a genuine interest in our people and their well-being, and our patients.

At Roche, the world’s largest biotech company you can, with the industry’s strongest pipeline in specialised medicines. Take pride in knowing you can make a difference to millions of patients worldwide developing treatments for oncology, neuroscience, inflammation, immunology, ophthalmology, rare diseases, and respiratory disease.

Anything’s possible, in a friendly, collaborative culture where people are united in purpose and will stretch you to be brave, speak up and think differently. Feel empowered to deliver meaningful outcomes, supported by accessible and inspiring leaders.

All facets of diversity are important to us and we endeavour to create an environment where everyone, regardless of factors such as gender, age, ability, race, ethnicity, sexual orientation, gender identification or religion, can contribute and realise their potential. As part of promoting diversity, we welcome applications from all people who are passionate about doing now what patients need next.

This role is only open to candidates that have full eligibility to live and work in Australia.

We do not accept any unsolicited resumes or enquiries from recruitment agencies. Roche has a dedicated in-house Talent Acquisition team.