Quality Projects Lead

POSITION SUMMARY

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 quality leadership

• Partner and collaborate with respective workstream leaders to embed Quality across all projects
• Define regulatory approval pathways and timelines to completion
• Develop Develop suitable KPIs and Quality goals to track and maintain compliance during Project lifecycle.
• Manage Quality risks and drive a proactive quality culture.

CQV and inspection readiness

• Provide hands-on support for commissioning, qualification, and validation (CQV).
• Review/approve FAT, SAT, IQ/OQ/PQ protocols and validation strategies/plans to relevant guidelines.
• Coordinate operational and regulatory inspection readiness with site functions.

Third‑party quality management

• Conduct quality reviews of suppliers and service providers.
• Lead/participate in audits; follow through on CAPAs.

Capital projects oversight

• Provide quality and regulatory input to capital project decisions and tenders.
• Endorse capital projects from a compliance perspective.

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 (or related).

· Experience with Australian regulatory environment for animal vaccines (e.g., APVMA, Dept of Agriculture, OGTR, SSBA).

· Hands-on quality experience in CQV.

TECHNICAL SKILLS REQUIREMENTS

· Certified Auditor Qualifications (Internal or External)

· Strong knowledge of the Australian cGMP, NZ Veterinary cGMPs, PIC/S and Annex 1 GMP

· Understanding of Quarantine Approved facilities and OGTR PC2 certification criteria

· Familiarity with vaccine manufacturing and contamination control strategies

· Demonstrated experience in project work and CQV (Commissioning, Qualification, and Validation) activities

· Supplier qualification program experience

· Hands‑on deviation and change control management.

· Proficiency with standard office software and virtual meeting platforms.

· Clear written and verbal communication; strong organization and presentation skills.

PHYSICAL POSITION/QUALIFICATION REQUIREMENTS

Our sites are GMP facilities with climate-controlled, clean, and classified areas.

This role is primarily office-based, with occasional entry into GMP production areas (controlled/classified zones). No special clothing is required for office-based activities (street attire).

When entering controlled areas, appropriate PPE and aseptic gowning are required in accordance with site policy and training.

Occasional overtime may be required to meet critical project milestones.