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Team Leader, Quality

3 weeks ago

Brisbane, Queensland, Australia Buscojobs Full time

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 of our 125,000+ outstanding colleagues has a unique story to tell.
Surrounded by collaborative teammates, you'll have the support and opportunities that only a global leader can provide
Our respected, growing organization has a strong strategic outlook for the near and long term.
Join our team and help us make a significant impact on the world
Position Summary : Lead quality systems for biopharmaceutical manufacturing, ensure compliance with TGA, FDA, EMA, and ICH standards, and report to the Head of Quality Assurance at Thermo Fisher Scientific's Brisbane site.
Location / Division Specific Information This is a full-time, permanent position based onsite at our Kent Street, Brisbane offices.
The role involves working within a team focused on manufacturing biopharmaceutical products in compliance with international quality standards such as TGA, FDA, EMEA, ICH, etc.
Key Responsibilities : Lead the daily operations of the Quality on the Floor Team, 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 promote high employee engagement and career growth.
Implement effective KPIs and goal-setting strategies to enhance team performance.
Align QA on the Floor team goals with overall Quality and business strategies.
Coordinate manufacturing activities to ensure compliance with cGMP and SOPs.
Manage the Quality on the Floor program for real-time quality support, including mentorship and document review.
Oversee batch record review within standard timelines for batch disposition.
Support continuous improvement initiatives to realize cost savings and efficiency gains.
Develop strong working relationships with internal departments.
Participate in Quality Management Reviews.
Assist in regulatory and client audits to ensure successful inspections.
Collaborate globally to develop and implement policies and procedures.
Apply risk assessment tools (e.g., FMEA, fishbone diagrams) reliably.
Utilize the Quality System daily, including Change Control, Deviations, CAPA, OOS / OOT, and Documentation Management.
Perform other duties as assigned 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 field or relevant industry experience.
Postgraduate qualifications are advantageous.
At least 1 year of leadership experience preferred.
Minimum of 4 years' experience in Pharmaceutical and / or Biotechnology industries related to Quality Assurance.
Extensive knowledge of cGMP required.
Ability to thrive in a dynamic, changing environment.
Strong communication skills (written, verbal, interpersonal).
Collaborative skills to build trust internally and externally.
Proficiency in Microsoft Office; knowledge of SmartSheets is desirable.
Australian citizenship or permanent residency is required.
Skills & Attributes : Continuous Improvement : Ability to challenge the status quo for better outcomes.
Adaptability : Flexibility to meet day-to-day business needs.
Collaboration : Ability to work effectively with diverse teams.
Customer Focus & Integrity : Commitment to delivering on promises.
Initiative : Ability to work independently and manage multiple projects.
Leadership : Balancing customer demands with business needs and timelines.
Quality Orientation : Strong attention to GMP principles and detail orientation.
Other Important Information : The manufacturing of biopharmaceuticals must comply with international quality standards.
The Quality Control Department develops, validates, transfers, and performs all tests to ensure compliance.
The Brisbane site is a multi-product facility producing clinical trial pharmaceuticals (Phase I-III).
Benefits : Health & Wellbeing : Comprehensive benefits, wellness programs, and confidential support through Employee Assistance Programs.
Flexibility : Flexible work arrangements.
Extra Leave : Generous leave policies, including purchase options, paid birthday leave, and parental leave.
Charitable Giving & Volunteering : Paid volunteer time for non-profit support.
Learning & Development : Access to online courses, workshops, and mentorship to support career growth.
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.
We value diverse experiences, backgrounds, and perspectives.
Join us and start your story today at Thermo Fisher Scientific.
Apply now at .
Thermo Fisher Scientific is an EEO / Affirmative Action Employer.
We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or other protected categories.
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