Quality Projects Lead

POSITION SUMMARY - Temporary position for 2 years.

This position is responsible for providing guidance, direction and expertise, in accordance with Zoetis Global Quality Standards & Global Regulatory Guidelines, on all site projects and activities for the transition of property ownership, site functions and operational readiness within Zoetis GMS Melbourne Site. This role involves establishing Quality and Regulatory standards across project workstreams including developing the Regulatory approval pathway and timelines.

The Quality Projects Lead will report to the Internal Manufacturing Site Quality Leader ANZ and work directly with the Program Lead.

POSITION RESPONSIBILITIES

Project Support for Site Transition and Operational readiness

Partner and collaborate with respective workstream leaders to implement on Quality matters.

Provide hands-on support and effective communications to project teams.

Provide Regulatory approval pathways and timelines for completion

Maintain Quality compliance, manage Quality risk and drive a proactive and positive culture.

Develop suitable KPIs and Quality goals to track and maintain compliance during Project lifecycle.

Quality Reviews and Improvements for Third-Party Suppliers

Perform Quality reviews of third-party suppliers.

Lead and/or participate Quality audits as requested by the project leads.

Review and Endorse Capital Projects

Review and endorse capital projects from a Quality/Regulatory perspective.

Perform Quality reviews for key business decisions such as capital projects.

Support tender activities with emphasis on Quality due diligence.

ORGANIZATIONAL RELATIONSHIPS

Site Manufacturing and Support Teams

Site Leadership & Enabling Functions

Cross functional teams within GMS & GMT

External parties including suppliers & service providers

EDUCATION AND EXPERIENCE

Bachelor’s Degree in Science and experience in the Australian regulatory environment for animal vaccines (APVMA, Dept of Agriculture, OGTR & SSBA)

TECHNICAL SKILLS REQUIREMENTS

Certified Auditor Qualifications (Internal or External)

Proven Organisation skills

Presentation skills

High level of knowledge of the Australian cGMP and the Australian / NZ Veterinary cGMPs

Knowledge of the Zoetis Quality Standards and Zoetis Global Systems

High level knowledge of Quarantine Approved Premises Criteria

Knowledge of vaccine manufacturing processes

Communication skills (interpersonal and written)

Computer literacy in word processing, spreadsheet analysis, presentation software and database software.

Ability to navigate & operate virtual meetings in various platforms

PHYSICAL POSITION/QUALIFICATION REQUIREMENTS

This role is located at the Melbourne , Parkville site and is an on site role.

The sites are GMP facilities with climate & environmentally controlled with clean and classified areas within.

This position is located both in an office environment and within the Production areas. The incumbent will be required to wear various manufacturing suits dependent on the production activities being performed.

The attires include:

Lab coat, steel-capped safety boots, hairnet, beard snood (where applicable), and safety glasses (where sign-posted)

Primary gowning (for controlled area work)

Secondary gowning consisting of sterile gown, boots, mask, gloves, and safety glasses/ googles (for aseptic operations)

No special clothing requirements for all office-based activities (street clothes only)

This job requires the employee to work overtime as needed.