Life Science Project Manager — GMP/CQV Expert

PSC Biotech® Corporation; Melbourne; On-site; AUD 120,000 - 180,000; Full time

Job summary

PSC Biotech® Corporation in Melbourne seeks a Project Manager to coordinate and oversee all project aspects, ensuring on-time delivery and budget adherence within GMP-regulated environments.

The role requires strong CQV experience, cross-functional leadership, and the ability to manage risks, vendor communications, and document control to support validation and quality policies. This position is on-site in Melbourne and offers growth within a growing biopharma services company.

Qualifications

• 7-10 years of related experience in Life Science sector.
• 4+ years’ experience with project management in GMP-regulated environments.
• Min 3 years of expertise in CQV or Fill Finish within GMP-regulated environments.
• Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
• Proficient in developing SOPs, final reports and validation & quality policies.
• Understanding of cost and risk management in projects.

Responsibilities

• Coordinate and oversee all aspects of assigned projects with internal and external stakeholders.
• Support cost and schedule management across multiple concurrent projects.
• Execute project implementation in alignment with management direction.
• Lead CQV activities for facilities, utilities, and equipment.
• Write and review GMP/GDP documentation and technical specifications.
• Partner with cross-functional teams to deliver project milestones.
• Lead risk analyses and design reviews; coordinate FAT, SAT, IQ, OQ, PQ activities.
• Mentor clients and internal teams; manage timelines and deliverables.

Skills

Relationship Building

Negotiation Skills

Organization

Analytical Skills

Rational Persuasion

Interpersonal Awareness

Agility

Education

Bachelor’s Degree in Engineering (Chemical or Mechanical) or Life Science relative degree

MBA or PM Certification

Job description

PSC Biotech® Corporation in Melbourne seeks a Project Manager to coordinate and oversee all project aspects, ensuring on-time delivery and budget adherence within GMP-regulated environments.

The role requires strong CQV experience, cross-functional leadership, and the ability to manage risks, vendor communications, and document control to support validation and quality policies. This position is on-site in Melbourne and offers growth within a growing biopharma services company.