Supervisor, Product Quality - Brisbane, Australia - Thermo Fisher Scientific

Thermo Fisher Scientific
Thermo Fisher Scientific
Verified Company
Brisbane, Australia

2 weeks ago

Olivia Brown

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Olivia Brown

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Description
Customers globally rely on our extensive range of products and services—

from life-saving medicines to lab essentials to next-generation instruments.

Our Operations team leverages our PPI (Practical Process Improvement Business System) to manufacture and produce these products and continuously improve productivity and quality all while contributing to our Mission - to enable our customers to make the world healthier, cleaner and safer.


Job Title:
Product Quality Supervisor


Reports to:
Head of Quality Assurance


Group / Division:
PSG / DSD


Career Band: 6


Job Family:
Quality


Job Sub Family:
Quality Assurance


Job Code:
OPS.QAOP.M06


Job Track:
Management


Position Location:
PSG Brisbane Australia


Number of Reports:6

***Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by TGA, FDA, EMA, ICH etc.

Reporting to the Head of Quality Assurance, this position is responsible for the Leadership of the Product Quality team. This is a leadership position hiring, managing, developing, appraising and mentoring the Product Quality team.


Key Responsibilities:


Provide leadership to the Product Quality team, hiring and developing staff to ensure appropriate resource and planning is in place to support business requirements.


Lead, coach, appraise and mentor a team of senior quality professionals to ensure employee engagement and career development is maintained for the team.


Lead and manage the team to provide QA oversight of product related quality including batch disposition, cGMP document review, Quality record review and validation document review.

This position and team are responsible for critical quality and business decisions related to product manufactured at the Brisbane site.


Deploy the team to provide Quality oversight and support to customer relations, being the primary Customer Interfacing Quality Assurance team, ensuring a best-in-class customer experience.

Team responsibilities include ownership of contractual discussions and the implementation of Quality Technical Agreements (Quality Agreements).


Interface with the global quality organisation on a regular basis to contribute to global quality policy and procedures and ensure on site alignment with these documents, driving tactical and strategic business objectives.

Support the team in implementing continuous improvement (PPI) initiatives that realise cost savings and drive efficiency.

Build effective working relationships with key internal collaborators from other teams and departments that foster a collaborative work environment.

Provide expert interpretation of Quality data as part of Quality Management Review and as required.

Day to day use of the Quality System, including Change Control, Deviations, CAPA, OOS/OOT, and Documentation Management.

Perform any other legitimate duties as directed by Head of Quality Assurance or Site quality Head.


Frequent Contacts:


Internal

  • All internal departments
  • Global Quality

External

  • Regulatory agencies
  • Customers

Minimum Qualifications & Experience

  • Tertiary education in science or engineeringbased field (i.e. biopharmaceuticals manufacture, biotechnology, process technology) or relevant industry experience.
  • Post Graduate qualifications beneficial
  • At least 3 years of experience in a leadership role.
  • At least 5 years' experience in the pharmaceutical industry aligned to Quality Assurance.
  • Very good knowledge of cGMP.
  • Desire to work in a highly dynamic, frequently changing environment with a wide variety of people and perspectives.
  • Strong written, verbal and interpersonal communication skills.
  • Strong collaborative skills with the ability to build rapport with internal and external stakeholders.
  • Good knowledge of SmartSheets desirable.

Skills & Attributes
Strong Leadership (Proven capability of leading a team of professional scientific staff)

Broad and detailed knowledge of pharmaceutical cGMP quality systems and associated international GMP regulations and guidelines

Strong planning, organising, problem solving and decision making skills

Continuous Improvement (Demonstrates the ability to challenge the status quo to improve outcomes)

Adaptability (Ability to adapt to day-to-day business requirements)

Collaborating (Demonstrates ability to work with all departments and colleagues of varied backgrounds)

Customer Focus and Integrity (Demonstrates the dedication and ability to deliver on promises made to internal or external customers. i.e., meet agreed due dates)


Other Important Information


Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by TGA, FDA, EMEA and ICH.

To achieve compliance, quality systems are defined, implemented, and maintained. The Quality Control Department is responsible for the development, validation, Technical Transfer as appl
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