Senior Associate - Quality System Operations

About the Role

At Pfizer, our commitment to quality ensures that patients receive safe and effective products every day. Our innovative and risk-based quality culture emphasizes flexibility and patient-first mindset. This role focuses on development, compliance, maintenance, and research analysis within the Quality Management System (QMS).

Key Responsibilities

• Assist in executing and maintaining QMS processes to meet Pfizer and regulatory standards.
• Manage quality training sessions, oversee change management, and monitor quality performance metrics.
• Participate actively in internal and external audits, including regulatory inspections and readiness preparations.
• Engage in quality risk management and ensure prompt completion of quality improvement initiatives.
• Support procedures related to product release and disposition as per licenses and protocols.
• Investigate deviations and product quality concerns, collaborating with cross-functional teams to implement corrective measures.
• Contribute to qualification and management of GMP/GDP suppliers and service providers.
• Ensure supplier compliance aligns with internal quality and regulatory requirements.
• Assist in customer screening and quality assurance within the supply chain network.
• Drive quality and business improvement projects across Australia and New Zealand.
• Build and maintain strong collaborative relationships with stakeholders to support compliant product supply.
• Foster a proactive quality culture and continuous improvement mindset within teams.
• Exhibit accountability, initiative, and effective communication to meet team goals.

Qualifications and Experience

• Tertiary qualification in Science, Pharmacy or related field is mandatory.
• At least 3 years’ experience in a pharmaceutical quality role.
• Proven ability to influence both internal stakeholders and external partners.
• Understanding of Australian and New Zealand legislation relevant to GMP, GDP, and QMS.
• Competence in technical writing, reporting, and critical thinking.
• Ability to work effectively both independently and within cross-functional teams.
• Proficiency in Microsoft Excel and Word.
• Proactive problem-solving skills.

Preferred Skills

• Hands-on experience with quality administration systems.
• Familiarity with electronic document control platforms.
• Strong organizational abilities and meticulous attention to detail.
• Experience in regulatory compliance documentation.
• Capability to mentor colleagues and review their work.
• Knowledge and usage of AI tools like ChatGPT or Microsoft Copilot to improve problem solving, productivity, and ethical AI practices.

Working Conditions and Benefits

This role is based onsite in Auckland, New Zealand, with a hybrid working model. Pfizer offers extensive benefits including paid parental leave, wellness app access, career development programs, rewards, volunteer leave, life insurance, learning resources, health screenings, additional leave purchase options, and salary packaging.

Diversity and Inclusion

Pfizer fosters a diverse workforce reflecting our patient communities, promoting equity and inclusion through various resource groups and workstreams. Reasonable adjustments during recruitment are supported.

Additional Information

Guidelines for acceptable and prohibited AI use during recruitment are available to candidates to ensure transparent and fair hiring practices.