Use Your Power for Purpose

Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.

What You Will Achieve

In this role, you will:

Combine site inspection management and internal audit activities in a developing corporate network setting requiring a limited amount of travel.Administrate and coordinate the inspection readiness program for regulatory inspections aligned with company objectives and oversee the execution of inspection activities and timely management of regulatory stream activities through to commitment implementation.Manage external (regulatory and corporate) audits and assure Company practices meet TGA, PIC/S GMP, FDA, MHRA, EMA, Health Canada, cGMP and other regulations. As member of a developing corporate internal auditor group, perform internal audits at the site as participant and internal audits at other IMOQ sites as Lead auditor.Partner with key stakeholders to provide direction and guidance on GMP Compliance mattersAdministrate the Site Quality Review Team (SQRT) and Ad-Hoc SQRTDrive a proactive quality culture across the Company to deliver products Right First Time (RFT).

Here Is What You Need (Minimum Requirements)

Bachelor’s Degree in Scientific or related discipline with 5 years experience or 3 of 5 years in a Quality function.Demonstrated experience working in a cGMP (current Good Manufacturing Practices) environment with strong understanding of Quality Systems functionsExperience in preparing and participating in audits and inspectionsSelf-motivated with a proven ability to deliver results in a team environmentExcellent technical writing, communication, and presentation skillsProficiency in Microsoft Office and Date Analytic ToolsAbility to travel

Bonus Points If You Have (Preferred Requirements)

Strong analytical and problem-solving skillsAbility to work independently and as part of a teamStrong interpersonal skills and the ability to communicate effectively with all levels of the organizationAbility to adapt to changing priorities and manage multiple tasks simultaneouslyExperience in mentoring and training colleagues  
Work Location Assignment: Hybrid

At Pfizer we care about our colleagues’ wellbeing and offer a range of great benefits for them, including:

Paid parental leave

Access to Health & Wellness apps

Career Growth Experiences program

Recognition & rewards program

Paid volunteer days

Life Insurance Benefits

Pfizer Learning Academy access to top content providers

Access to flu vaccines & skin checks

Options to purchase additional leave

Salary packaging & novated lease options

*Benefits listed may vary depending on your position and location and may be subject to change.

Pfizer Australia and New Zealand’s diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.

If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.

Quality Assurance and Control

#LI-PFE