Head of Quality Control

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information Position Location: Brisbane, Australia Number of Direct Reports: Approximately 4 (approximately 50 indirect) About the Role:The Head of Quality Control is accountable for the strategy, performance, compliance and sustainable delivery of the Brisbane Quality Control function. The role ensures reliable and timely delivery of analysis, review and reporting activities required to support raw material release, manufacturing operations, product disposition, stability programs, facility monitoring, method validation and contract testing. The role leads the QC organisation through its management team and is accountable for capacity planning, technical capability, data integrity, investigation performance, external laboratory oversight, digital systems, equipment lifecycle, inspection readiness and continuous improvement. The Head of QC ensures that the function operates in compliance with applicable GMP requirements while delivering right-first-time, customer-focused and commercially sustainable outcomes. As a member of the Quality Leadership Team, the role contributes to site quality strategy, governance, risk management and organisational capability. The role serves as the senior QC representative for the Brisbane site with customers, regulatory authorities, Thermo Fisher global Quality and QC networks, partner sites and technical subject matter experts, ensuring site priorities are represented and global requirements are translated into effective local execution. What You'll Do:Functional Leadership and StrategySet and execute the QC strategy in alignment with site and corporate Quality priorities, business demand and customer requirements. Lead the QC organisation through the QC management team, with clear accountability. Own QC planning and performance governance, including the Annual Operating Plan, labour and capacity modelling, CAPEX, KPIs and continuous improvement. Contribute as a senior Quality leader to governance, including Quality Management Review, inspection readiness and contamination control. Operational Delivery and CapacityEnsure timely delivery of QC testing, review and reporting activities in line with manufacturing, release, stability and customer requirements. Own QC capacity and resource planning, balancing demand, capability and business priorities. Monitor QC operational performance, including testing cycle times, right-first-time performance, backlog and adherence to agreed service levels. Ensure effective planning and utilisation of internal and external laboratory capacity. Identify and address capacity, capability and delivery risks, escalating material risks through appropriate site governance. Ensure effective and timely management of QC investigations, deviations, CAPAs, change controls and inspection commitments, including escalation of significant risks. Compliance, Data Integrity and Inspection ReadinessEnsure QC facilities, equipment, methods, systems, documentation and records comply with site procedures and applicable regulatory requirements. Maintain QC inspection readiness and act as the senior QC representative during customer audits, corporate audits and regulatory inspections Ensure effective and timely management of QC investigations, deviations, CAPAs and change controls, including escalation of significant risks. Own QC data integrity performance and maturity, ensuring ALCOA++ principles are embedded across paper, instrument and electronic records. Partner with the Contamination Control Manager on environmental monitoring and contamination-control oversight relevant to low-bioburden drug-substance manufacturing. Technical Capability, Methods and Laboratory SystemsEnsure fit-for-purpose analytical and microbiological capability for raw materials, in-process testing, drug substance, stability and facility monitoring. Provide governance across the analytical method lifecycle, including development, transfer, qualification, validation and troubleshooting. Own the lifecycle strategy for QC facilities, equipment and computerised systems, including investment, qualification, maintenance, obsolescence and business continuity. Lead laboratory digitalisation and simplification initiatives that improve compliance, capacity, review efficiency and right-first-time execution. People, Culture and Organisational CapabilityBuild and sustain a capable, accountable and appropriately structured QC organisation. Hire, coach and develop QC leaders, ensuring effective performance management and succession planning. Ensure QC personnel are trained, qualified and competent for assigned GMP, technical and safety activities. Global, Customer and Cross-functional LeadershipBuild effective relationships with global Quality, QC, analytical development and operational excellence teams to align Brisbane QC with network standards and strategy. Represent Brisbane QC in global forums and initiatives, communicating site risks, priorities and resource needs. Implement applicable global procedures, standards and harmonisation initiatives. Benchmark QC performance against network and industry practices, translating learning into improvement. Maintain timely client communication on QC performance, technical issues, investigations, changes, risks and recovery plans, including significant escalation Support global commercial teams with customer proposals, technical content, pricing and scope development. EducationBachelor’s degree in science or a relevant scientific discipline (e.g. biochemistry, chemistry or biology). Postgraduate qualification in a relevant discipline desirable. ExperienceMinimum 8 years of previous QC experience and/or Quality-related experience in biopharmaceutical manufacturing industry Experience within a Contract Development and Manufacturing Organisation (CDMO) environment preferred Good knowledge of current Good Manufacturing Practices (cGMP) Strong working knowledge of QC laboratory operations, including sample management and flow, raw material release, in-process controls, drug substance testing, laboratory equipment and associated quality systems Demonstrated experience supporting and/or leading customer audits and regulatory inspections. Demonstrated experience leading people and teams within a regulated Quality and/or QC environment. Ability to work in a highly dynamic, frequently changing environment with a wide variety of people and perspectives Knowledge, Skills, AbilitiesStrategic Leadership – Sets clear direction for QC, translates site and business priorities into actionable plans, and balances short-term delivery with long-term capability. Decision Making – Makes timely, risk-based decisions using scientific, quality and business judgement, including escalation where appropriate. Influencing & Collaboration – Builds alignment across functions, customers and global stakeholders, and effectively influences decisions in a matrix organisation. People Leadership – Builds high performing teams through clear accountability, coaching, performance management, succession planning and effective delegation. Managing Complexity – Prioritises effectively across competing operational, technical, regulatory and customer demands in a dynamic ma