Quality and Compliance Lead – Global Pharmaceutical

Our client is a global pharmaceutical company who develop breakthrough therapies that improve the lives of humans. Thye have a strong culture based on diversity and inclusion and are renowned for the development of their people. They have a solid portfolio of products that lead the market in varied therapeutic areas.

The Role

The Quality and Compliance Lead (QCL) is the Quality and Compliance expert within the Medicine Division that drives GvP / GcP topics across the company to pro-actively manage Quality and Compliance across the drug/device development.

In addition, the QCL will also lead the organization to identify and mitigate risks through drug/device development to ensure patient safety and data integrity.

This role will also initiate and manage any quality and compliance topics to continuously improve the Medicine Quality Management System.

This role will directly report to the Head of Quality Medicine.

Tasks & Responsibilities

Maintain all aspects of the global Medicine Quality Management System and tailoring to comply with local regulatory requirements.

Implementation and maintenance of global procedures and ensure adherence to the local regulatory and business requirements.

Participation in inspections end to end activities, representing the company compliance position during inspections and ensuring inspection findings are addressed and responses provided.

Ensure audit findings are appropriately investigated, actions are effectively implemented, and lessons learnt are implemented

Provide quality analysis and trending across Medicine Functions.

Lead as the subject matter expert (in partnership with the business key stakeholders) in Non-Compliance management and Issue Management processes. Ensure effective triaging, root cause analysis investigation and CAPA development delivering robust CAPAs

Requirements

Master’s degree or Bachelor of Science / Life Science / Biomedical Sciences / Pharmacy

Minimum at least 4-5 years in a quality assurance / PV position within the pharmaceutical industry

Preference for Pharmacovigilance, Regulatory Affairs and/or Medical Affairs experience

Effective communication skills

Proven track record of effective collaborations with business partners

Ability to act independently on given tasks and be a good team player

Well versed in local regulations

About EP Healthcare

Why work with EP Healthcare? We specialise in recruitment within the pharmaceutical and Medical Device Industry. We have developed an outstanding network of clients, as well as a very thorough knowledge of the Healthcare industry. How? Because we’ve all worked in it ourselves as reps, managers, and marketers – not just recruiters! We support our candidates by offering a personalised and experienced approach, every step of the interviewing process.

Click the APPLY button to send your CV.

If you would like further information before sending your CV, please call Lisa Fox on 0488 022 779 or Maryann Bastac on 0438 114 314 for a confidential chat.

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