Quality Systems Manager

Summary about this job

Detail information about job Quality Systems Manager. Terms and conditions vacancy

• Join a global pharmaceutical company in an exciting growth phase
• Great benefits: bonus, car allowance, extra leave days, free parking & gym
• Combine your leadership and quality systems experience in a global organisation

At AstraZeneca we lead with the science first and foremost. As a patient centric global pharmaceutical company, we know that strong science leads to clinical innovation and the right medicine for the right patient. We are also excited about our enviable pipeline across many therapeutic areas. Importantly, we are keen to meet people who are passionate about the science and who want to make an impact on people’s lives. AstraZeneca Australia is going through an exciting growth phase and you can be part of it! We have invested more than $200 Million in the last 8 years and our site continues to grow.

We have an opportunity for a Quality Systems Manager at our North Ryde Manufacturing Division.

This position reports to the Site Quality Director and is responsible for the maintenance and improvement of the Pharmaceutical Quality System (PQS) in North Ryde.

Key Responsibilities:

• Effectively manage various Quality Systems, i.e. Deviation and CAPA, Change Control, Customer Complaints, PQRs, Supplier Management , Internal and External Audit management and Quality Risk management.
• Effectively manage compliance to the Marketing Authorisation for all products manufactured on site.
• Take end to end ownership to resolve quality compliance issues, coordinating key stakeholders to reach a resolution.
• Develop strategies to assure ongoing compliance and streamline processes to maximise benefit and reduce complexity.
• Ensure systems are in place to report and track quality KPIs and incidents to Global and site senior management via reporting systems and quality management review meetings.
• Effective recruitment and talent management including individual development planning and supporting career development of direct reports.
• Performance management including setting performance objectives and conducting timely performance appraisals, optimising performance outcomes of direct reports and ensuring all team members behave within the Ethical Conduct and Compliance guidelines.
• Comply with all systems, processes and procedures in line with statutory/ legislative/ quality requirements.
• Conduct all activities in accordance with AstraZeneca Code of Conduct and all relevant compliance codes and regulations.

About you:
You will be tertiary qualified in a science or quality related discipline and have significant experience in a Pharmaceutical/Technical environment in Quality Assurance. In addition to that, some essential skills required to be successful in the role are:

• Appropriate management skills developed either by formal education or previous experience in a managerial role
• Exceptional written and verbal communication skills
• Ability to interpret requirements prescribed within cGMP guidelines and apply these principles to maintaining compliance standards
• Demonstrated experience in management of pharmaceutical quality systems including quality control and quality assurance experience

Most importantly, you are driven, proactive, confident and passionate about Quality and committed to delivering the best outcome for patients.

Join AstraZeneca at an exciting time, and enjoy a range of benefits such as 10% super, bonus, car allowance, leave loading, extra leave days, free parking & gym membership.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country where the role is advertised.