Quality Assurance Team Supervisor

1 week ago

Brisbane, Queensland, Australia Thermo Fisher Scientific Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

About Thermo Fisher Scientific:

Thermo Fisher Scientific Inc. stands as a global leader in the scientific community, generating annual revenues surpassing $44 billion. Our mission is to empower our clients to create a world that is Healthier, Cleaner, and Safer. Whether assisting in life sciences research, tackling complex analytical challenges, enhancing patient diagnostics and therapies, or boosting laboratory efficiency, we are dedicated to supporting our customers. Our workforce of over 125,000 professionals provides an exceptional blend of innovative technologies, purchasing convenience, and pharmaceutical services through our renowned brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

Position Overview:

The manufacturing of biopharmaceutical products must align with international quality standards as defined by TGA, FDA, EMA, ICH, etc. This position reports to the Head of Quality Assurance and is situated in Brisbane. The primary focus of this role is to oversee a team responsible for the development, implementation, updating, auditing, and reporting on the status of Quality Systems while ensuring compliance with the TGA Manufacturing License.

Key Responsibilities:

  • Manage the daily operations of the Materials Management Team, including planning, execution, and reporting of activities that drive key performance indicators.
  • Establish and uphold the Materials Management function as a vital element of the Quality Assurance department, significantly contributing to the site's management system.
  • Lead the Materials Management Team in developing and maintaining critical metrics related to all key systems owned by the team, ensuring employee engagement and career development.
  • Support the team in executing continuous improvement initiatives that yield cost savings and enhance efficiency.
  • Foster effective working relationships and collaborate with key internal stakeholders.
  • Oversee all aspects of the article code system, supplier change notifications, supplier qualification, and supplier quality agreements, providing training and consultation support.
  • Engage in Quality Management Reviews and assist in regulatory and client audits, facilitating successful inspection outcomes.
  • Collaborate globally and on-site to create and implement policies and procedures.
  • Lead the practical application of various risk assessment tools and advise others on their efficient application.
  • Utilize the Quality System daily, including Change Control, Deviations, CAPA, OOS/OOT, and Documentation Management.
  • Collaborate with all internal departments, vendors, contractors, regulatory agencies, and customers.

Qualifications:

  • Tertiary education in a science or engineering-related field (e.g., biopharmaceutical manufacturing, biotechnology, process technology) or relevant validated experience and/or Post Graduate qualifications.
  • A minimum of 1 year of leadership experience.
  • Demonstrated experience in the pharmaceutical industry related to Quality Assurance.
  • In-depth knowledge of cGMP.
  • A desire to thrive in a dynamic, frequently changing environment with diverse perspectives.
  • Strong written, verbal, and interpersonal skills, with the ability to build trust with internal and external customers.
  • Proficient in Microsoft applications; knowledge of Smart Sheets is desirable.
  • A continuous improvement mindset.
  • Adaptability and excellent time management skills.
  • Customer-focused with integrity.
  • A natural problem solver and positive relationship builder.
  • Quality-oriented with the ability to interpret and apply GMP principles.
  • Strong attention to detail and accuracy in completing test records.

Employee Benefits:

  • A competitive salary and performance-related bonus structure.
  • Access to Thermo Fisher's global University.
  • Exposure to market-leading and innovative technologies.
  • Career development opportunities within a leading global organization.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

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