Supervisor, Qa

Description:

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
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:
The Brisbane Quality Control Department focuses on the development, validation, technical transfer and performance for all tests and validation of QC Equipment. The site is a multi-product biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for clinical trials (Phase I, II & III).
About the Role:
The role reports to the Head of Quality Assurance (QA), and leads the Product Quality team, passionate about driving excellence and encouraging a collaborative, world-class environment. Your leadership will be pivotal in achieving ambitious goals.
What You'll Do:
- Provide leadership to the Product Quality team, hiring and developing staff to ensure appropriate resource and planning is in place to support business requirements.
- Responsible for the performance of the team through the development and application of effective key performance indicators and goal setting aligned to Quality and business strategy.
- Provide QA oversight of product related quality including batch disposition, cGMP document review, quality record review and validation document review, and for critical quality and business decisions related to product manufactured at the site.
- Deploy the team to provide Quality oversight and support to customer relations, ensuring an outstanding customer experience.
- Lead team in contract discussions and implement Quality Technical Agreements. Collaborate with global and local quality teams.
- Support the team in implementing continuous improvement initiatives that realize cost savings and drive efficiency.
- Build effective working relationships with key internal collaborators from other teams and departments.
- Interpret quality data for Quality Management Reviews, participate in audits as an SME, deploy Quality Systems team, and support inspection readiness.
- Use different risk assessment tools, like FMEA and fishbone diagrams for efficient application.
- Day-to-day use of the Quality System, including Change Control, Deviations, CAPA, OOS/OOT, and Documentation Management.
- Collaborate with all internal departments and with external Regulatory agencies and customers.
Keys to Success:
Education:
- Tertiary education in Science or Engineering-based field (i.e. biopharmaceuticals manufacture, biotechnology, process technology) or relevant validated experience.
Knowledge, Skills, Abilities:
- Demonstrated ability - 3-5yrs - in a leadership role preferably from within the pharmaceutical industry aligned to Quality Assurance.
- Strong interpersonal skills - both written and verbal and strong collaborative skills with the ability to build rapport with clients, associates, and colleagues.
- Good knowledge of Microsoft applications and SmartSheets - desirable.
- Broad and detailed knowledge of pharmaceutical cGMP quality systems and associated international GMP regulations and guidelines.
- Strong planning, organizing, problem-solving and decision-making skills; and a continuous improvement demeanor, willing to challenge to improve outcomes.
- Ability to adapt to day-to-day business requirements and ability to deliver on promises made to internal or external customers. i.e., meet agreed due dates.
Benefits:
Join the team and take advantage of these benefits! Apply now to learn more about the full range of benefits we offer.
- Company prioritizes your health & wellbeing with benefits, wellness programs, and support services.
- 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 (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific (https://corporate.thermofisher.com/us/en/index.html) , 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.
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.