QC Support Manager

Role Summary
Working with Pfizer's dynamic Quality Control (QC) Support team, you will champion compliance and continuous improvement across Pfizer Melbourne's Chemistry and Microbiology laboratories. You will drive operational excellence, foster a culture of innovation, and collaborate with global networks to deliver safe and effective products to patients. Your leadership will shape laboratory design, process optimisation, and data integrity, ensuring our teams meet the highest standards of quality and regulatory compliance.

Aided by laboratory managers and coordinators, the QC Support Manager is accountable for stability management, method validation, and QC's key compliance activities – Change Control, investigations, corrective and preventative actions (CAPA) and Annual Product Quality Review (APQR) preparation. The position ensures that test methods produce reliable and accurate results, that the nature of our products is understood, and that necessary change is implemented effectively. As part of broader Quality community, you will reinforce behaviours that help us achieve our goal of providing the best healthcare to our patients.

As a member of the Extended Leadership Team (ELT) you will optimise the supply of world-class, life-saving medicines to our patients by;

Leading cross-functional collaborations to build a culture of understanding, belief and a commitment to excellence.

Foster Change & Enable timely decisions that are consistent with the site's Strategic Direction, Goals, Priorities and the Pfizer Blueprint 2.0.

• Promoting Growth and Wellbeing by developing a strong culture of Recognition, Inclusivity, Equity and Diversity.

Fostering simplification, removing roadblocks and empowering continuous improvement.

Working as a cohesive team to build trust through Joy, excitement and knowledge.

As an ELT member, you are united by this shared purpose, recognise that we are custodians of the site's integrity, and commit to act by our company values of courage, excellence, equity and joy.

Strategic Operational Leadership

• Manage people, budgets, and technology to deliver operational plans that meet organisational and regulatory requirements.
• Implement innovative systems and improvement initiatives to enhance performance.

Team Development and Leadership

• To develop and maintain a work culture and practices that enable the laboratory to better meet business demands while sustaining Good Manufacturing Practice compliance
• Guide, coach, and mentor team members, fostering a culture of continuous learning and development.
• Ensure team accountability and alignment with organisational values and objectives.
• Participate as an active member of the Quality Leadership Team and site's Extended Leadership Team (ELT).

Quality and Compliance Management

• Accurate and timely assessment of out of specification (OOS) and out of trend (OOT) results.
• Preparation of QC-related components of annual product quality reviews
• Determination and implementation of corrective and preventative actions
• Initiation and administration of Change Control records.
• Oversee and review deviations, CAPAs, audits, and regulatory documentation to ensure compliance with Pfizer's standards and global regulatory requirements.
• The oversight of the product stability program, test method validation/verification and compendial compliance programs.

Cross-
*Functional*
Collaboration

• Collaborate with cross-functional teams to enhance laboratory design, refine manufacturing and QC processes, and seek operational efficiency.
• Partner with stakeholders across departments to foster open communication and align on quality objectives.
• Address complex challenges and implement solutions.

Process Optimisation

• Drive simplification and efficiency by challenging and influencing practices, policies, and structures.
• Lead efforts to deliver cost savings and align with best practices.

Resource Allocation and Planning

• Effectively delegate tasks, manage team workloads, and allocate resources to meet business priorities.
• Oversee and evaluate customer feedback to enhance service levels.

Performance Metrics and Improvement

• Review and update business unit performance metrics, ensuring continuous improvement concepts within the QC Support team and wider QC organisation through data analysis and actionable insights.
• Support validation and assay development plans to meet timelines.

Other

• Adhere to code of conduct policies, engage in special project teams, manage delegated tasks, foster a progressive team culture, and support continuous improvement initiatives, and
• Other duties and responsibilities within the Quality Function including Systems, Compliance, Quality Assurance and Quality Control.

Qualifications & Experience

• Minimum Bachelor's Degree in Science or related discipline combined with more than seven (7) years of relevant experience.
• Demonstrable management experience with a track record of establishing and/or leading effective teams that has contributed to organisational outcomes.
• Demonstrated understanding of Good Manufacturing Practice systems, along with industry practices, regulations, and safety standards.
• Excellent attention to detail and time management skills to prioritise tasks.
• Demonstrated communication and interpersonal skills to engage with and collaborate with stakeholders.
• Ability to work within a team with self-motivation and a willingness to initiate and support productivity improvement changes.
• Ability to troubleshoot complex issues and solve problems using clear information and/or known solutions.
• Proven project and change management skills.

Desirable

• Previous experience in pharmaceutical or food industries.
• Familiarity with Six Sigma and Lean principles.
• Experience in Production or Quality departments.

Work Location Assignment: On Premise

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