Qc Microbiology Manager

We're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place.
To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those goals.
Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
Why Patients Need YouEverything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer-oriented. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution will directly impact patients.
What You Will AchieveThe Quality Control (QC) Microbiology Manager is responsible for the management and leadership of people, technology, and budgets to support Manufacturing Operations. Overseeing the QC Microbiology (QCM), Environmental Monitoring, QCM, and Validation Compliance units, the position is responsible for the implementation of innovative improvement plans and Quality systems, providing expert advice to key customer departments and enabling meeting GXP standards.
As a member of the Extended Leadership Team (ELT), you will play a critical role in optimizing 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; enabling timely decisions that are consistent with the site's goals and priorities; promoting wellbeing and developing a strong culture of inclusivity, equity, and diversity; fostering simplification, removing roadblocks, and empowering continuous improvement and working as a cohesive team to build trust, excitement, and knowledge.
How You Will Achieve ItTechnical Challenge, influence, and support practices, policies, systems, attitudes, and structures to enhance and ensure compliance, and alignment, with global regulatory requirements and Global Quality Standards.
Support the implementation of improvement plans to meet site strategic objectives.
Ensure appropriate service levels are met and maintain a high level of quality and GXP in a highly regulated facility.
Responsible for the review of relevant deviations and CAPA related records, and quality documentation (including validation documentation and risk assessments).
Participates in the review of key performance targets and assists in the development of future performance targets to meet quality, customer, and cost targets.
Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise, and coach their team.
Ensure active presence in the GMP work area and observe the work activity and practices within their role responsibilities.
Act as IMEx Element Owner and perform Structured Gemba.
Ensures all procedures within the QC and aseptic support business units meet the relevant compendial standards and are performed to these standards.
Supports quality audits to ensure processes are performed according to regulatory requirements (i.e. promotes and manages regular internal quality/product compliance audits).
Ensures all OOS and non-compliance investigations and reporting functions within the Business Unit are managed in a timely fashion and corrective/preventative measures implemented in a timely fashion.
Manages the review and updating of documentation to ensure it is maintained, up-to-date, and accurate.
Ensures that satisfactory audit, calibration, validation, and maintenance systems are established and managed within the business unit.
OOS investigations reviewed periodically for adverse trends.
Ensures that testing and validation schedules are monitored and manages the timely feedback to customer and planning manager when delays to product availability occur.
Collaborate effectively across Quality teams, fostering open communication and facilitating seamless coordination of activities and projects to achieve shared objectives and deliver high-quality results.
Implements and manages customer feedback on business unit performance.
Facilitates discussion and actions-based performance metrics for the QC Business Unit.
Report and display on the performance measures on site and corporately according to required timelines (weekly, monthly).
Support validation/assay development plans through technical review and resource allocation where required to achieve timelines.
Manage complex projects, including the development of work plans for self and others to achieve agreed output and targets, reporting any delays, and resolving or escalating as necessary issues that arise.
Leadership Effectively delegate tasks and responsibilities, leveraging the strengths and capabilities of team members, while providing clear instructions, guidance, and support to ensure the successful completion of assigned tasks and the efficient utilization of resources.
As a member of the extended Leadership team, participate in cross-functional activities to enable a culture of excellence.
Provide leadership to deliver a culture of excellence with a focus on HSE risk management, colleague growth and recognition, ensuring that values are upheld and holding colleagues accountable for their actions.
Provide mentorship, coaching, and training to colleagues, sharing expertise, knowledge, and best practices to support their professional development and ensure a high level of competency within the team.
Create and foster an environment in which there is a high level of cooperation within and between teams. Facilitate positive team relationships to build interactions across Department and the site.
Participate as an active member of the Extended Leadership team and regional and global network forums, share best practices and influence Operations.
Adhere to the spirit and practice of Pfizer Values, ensuring and promoting adherence to Pfizer's Environment, Health and Safety (EH&S) policies and procedures.
QualificationsMust-HaveA minimum Bachelors Degree in Chemistry, Science or Engineering combined with at least 5 years experience.
Demonstrated management experience with a track record of establishing and/or leading effective teams that have contributed to organizational outcomes.
Demonstrated experience in Quality Control including extensive knowledge of Good Manufacturing Practices (also cGMP) compliance requirements for Quality Control Laboratories, application of compendial methods and experience with a wide range of analytical techniques.
In-depth understanding of aseptic processing and monitoring procedures.
Reasoning ability including strong analytical and problem-solving abilities.
Demonstrable initiative and ownership in resolving issues or challenges.
Excellent written and verbal communication skills.
Demonstrable ability to plan and organize priorities and initiate timely issue resolution mindful of customer service requirements.
Nice-to-HaveKnowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.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
Recognition & rewards program
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.
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