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 Strategy Set 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 Capacity Ensure 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 Readiness Ensure 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 Systems Ensure 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 Capability Build 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 Leadership Build 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. Education Bachelor’s degree in science or a relevant scientific discipline (e.g. biochemistry, chemistry or biology). Postgraduate qualification in a relevant discipline desirable. Experience Minimum 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, Abilities Strategic 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 manufacturing environment. Customer Focus – Understands customer requirements, communicates clearly, manages expectations and delivers sustainable outcomes without compromising quality or compliance. Continuous Improvement – Challenges existing ways of working and drives measurable improvements in quality, delivery, efficiency and organisational effectiveness. Quality & Compliance Leadership – Applies strong GMP and scientific judgement, promotes a proactive quality culture and ensures risks are identified, escalated and addressed appropriately. Physical Requirements / Work Environment Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment Adhere to the Chain of Responsibility obligations under the Australian Heavy Vehicle National Law Abide by all EH& S policies and procedures Work safely and only perform tasks if currently competent and/or authorised Report hazardous conditions, hazardous actions, incidents and near-miss incidents Participate in EH&S activities (such as inspections and risk assessments) Not knowingly pollute the environment Benefits Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer. Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues. Flexibility: Balance your work and personal life with flexible arrangements. Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave. Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you. Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development. Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 125,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific , where diverse experiences, backgrounds and perspectives are valued. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.