JOB DESCRIPTION

At Thermo Fisher Scientific, each one of our 125,000+ outstanding minds has a unique story to tell. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you! Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world!

POSITION SUMMARY:

Lead quality systems for biopharmaceutical manufacturing, ensure compliance with TGA, FDA, EMA, and ICH, report to Head of Quality Assurance at Thermo Fisher Scientific’s Brisbane site.
Location/Division Specific Information
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.

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 highly 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.

• 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.