Life Sciences Project Manager - CQV & GMP

PSC Biotech; Melbourne; Presencial; AUD 110.000 - 170.000; Jornada completa

Descripción de la vacante

PSC Biotech is seeking a Project Manager in Melbourne to coordinate GMP-regulated projects across CQV activities, including validation, documentation, and cross-functional collaboration.

The role requires extensive experience in CQV or Fill Finish within GMP environments, strong leadership, and the ability to manage budgets and timelines while ensuring quality and regulatory compliance.

Formación

• Bachelor’s degree in engineering or life sciences; MBA/PM cert preferred.
• 7–10 years in Life Science sector; 4+ years PM in GMP environments; CQV/Fill Finish focus.

Responsabilidades

• Coordinate all aspects of assigned projects with internal and external vendors.
• Support cost and schedule management across multiple concurrent projects; ensure regulatory compliance and on-time delivery.
• Execute project implementation in alignment with management direction.
• Write and review GMP/GDP documentation and technical specifications.
• Lead risk analyses, design reviews, and CQV activities (FAT, SAT, IQ, OQ, PQ).
• Mentor clients and internal teams; manage timelines and deliverables.

Conocimientos

Relationship Building

Negotiation Skills

Organization

Analytical Skills

Rational Persuasion

Interpersonal Awareness

Agility

Educación

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

MBA or PM Certification

Descripción del empleo

PSC Biotech is seeking a Project Manager in Melbourne to coordinate GMP-regulated projects across CQV activities, including validation, documentation, and cross-functional collaboration.

The role requires extensive experience in CQV or Fill Finish within GMP environments, strong leadership, and the ability to manage budgets and timelines while ensuring quality and regulatory compliance.