Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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. 

Key Responsibilities:

Lead the Quality on the Floor Team daily, including planning, execution, and reportingEstablish and maintain the team as a vital component of the Quality Assurance department, contributing to the site's quality management systemLead, 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:

All internal departments

External: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 advantageousExtensive knowledge of cGMP requiredAbility 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 requiredSkills & 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 Quality Control Department is responsible for developing, validating, transferring, and performing all tests, as well as ensuring alignment with these requirements. The Brisbane site is a multi-product biopharmaceutical facility, developing and manufacturing pharmaceutical products for clinical trials (Phase I, II, and III).

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.

Apply today! http://jobs.thermofisher.com

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.