Overview
Lead quality systems for biopharmaceutical manufacturing, ensuring compliance with TGA, FDA, EMA and ICH. Report to the Head of Quality Assurance at Thermo Fisher Scientific's Brisbane site. This is a full-time permanent position based onsite at Kent Street, Brisbane, within the team focused on manufacturing biopharmaceutical products in compliance with international quality requirements as defined by TGA, FDA, EMEA and ICH.
Location / Division
This role is a full-time permanent position, based onsite at our Kent Street, Brisbane offices. The role sits within the team focused on the manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by TGA, FDA, EMEA, ICH, etc.
Responsibilities
* Lead the Quality on the Floor Team daily, including planning, execution, and reporting
* Establish and maintain the team as a vital component of the Quality Assurance department, contributing to the site's quality management system
* Lead, coach, and mentor team members to ensure high employee engagement and career development
* Implement effective key performance indicators and goal setting to lead team performance
* Align QA on the Floor team goals with Quality and business strategy
* Coordinate manufacturing activities to align with cGMP and standard operating procedures
* Coordinate the Quality on the Floor program for real-time quality support, including cGMP mentorship and document review
* Lead batch record review within standard timelines for batch disposition
* Support continuous improvement (PPI) initiatives to realize cost savings and drive efficiency
* Develop effective working relationships with internal collaborators across various departments
* Engage with Quality Management Review
* Assist in regulatory and client audits, ensuring successful inspection outcomes
* Collaborate globally to build and implement policies and procedures
* Apply and advise on risk assessment tools reliably (e.g., failure mode effect analysis, fishbone diagrams)
* Use the Quality System daily, including Change Control, Deviations, CAPA, OOS/OOT, and Documentation Management
* Perform additional duties as advised by the Head of Quality Assurance or Site Quality Head
Frequent Contacts
* Internal
o All internal departments
* External
o Regulatory agencies and customers
Minimum Requirements / Qualifications
* Tertiary education in a science or engineering-based field, or relevant industry experience
* Post Graduate qualifications are beneficial
* At least 1 year of experience in a leadership role preferred
* A minimum of 4 years' experience in the Pharmaceutical and/or Biotechnology industry aligned with Quality Assurance advantageous
* Extensive knowledge of cGMP required
* Ability to thrive in a dynamic, frequently changing environment
* Strong written, verbal, and interpersonal communication skills
* Strong collaborative skills to establish trust with internal and external collaborators
* Proficiency in Microsoft applications; knowledge of SmartSheets is desirable
* Australian citizenship or permanent residency required
Skills & Attributes
* Continuous Improvement: Demonstrates the ability to challenge the status quo to improve outcomes
* Adaptability: Ability to adapt to day-to-day business requirements
* Collaborating: Ability to work with all departments and colleagues of varied backgrounds
* Customer Focus and Integrity: Dedication to delivering on promises to internal or external customers
* Initiating Action: Ability to work independently and lead planned work, including multiple projects or tasks simultaneously
* Leading Relations: Balances customer demands with business requirements and agreed timelines
* Quality Orientation: Ability to interpret and apply GMP principles, demonstrating strong attention to detail and accurate completion of test records
Other Important Information
Manufacturing of biopharmaceutical products must align with international quality requirements. The Brisbane site is a multi-product biopharmaceutical facility, developing and manufacturing pharmaceutical products for clinical trials (Phase I–III).
Benefits
* Health & Wellbeing: Comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues
* Flexibility: Flexible work arrangements
* Extra Leave: Generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave
* Charitable Giving & Volunteering: Paid volunteer time to support non-profit organizations
* Learning & Development: Access to Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs
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.
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