Global Sterility Assurance Director - Quality & Operations

PCI Pharma Services; Philadelphia (Philadelphia County); On-site; USD 120,000 - 150,000; Full time

Job summary

PCI Pharma Services in Philadelphia is seeking a Sterility Assurance leader to develop a strategic roadmap and establish global quality standards for aseptic processing. This role focuses on mentoring microbiologists and ensuring compliance with regulations.

A bachelor's degree in Microbiology is required, along with 12-15 years of experience in a GxP environment. Preferred qualifications include a master's degree and expertise in EU GMP standards. Join PCI in delivering life-changing therapies in an inclusive environment.

Qualifications

• 12-15 years of experience in Sterility Assurance or Industrial Microbiology.
• Proven expertise in EU GMP Annex 1 and USP <797>/<800> standards.
• Exceptional teaching and mentoring skills.

Responsibilities

• Develop and execute strategic roadmap for sterility assurance.
• Establish global quality standards for aseptic processing.
• Lead development of Site-Specific Contamination Control Strategies.

Skills

Leadership skills

Microbiology knowledge

Analytical skills

Advanced computer skills

Communication skills

Education

Bachelor's degree in Microbiology or related field

Master's degree or PhD in Microbiology

Job description

PCI Pharma Services in Philadelphia is seeking a Sterility Assurance leader to develop a strategic roadmap and establish global quality standards for aseptic processing. This role focuses on mentoring microbiologists and ensuring compliance with regulations.

A bachelor's degree in Microbiology is required, along with 12-15 years of experience in a GxP environment. Preferred qualifications include a master's degree and expertise in EU GMP standards. Join PCI in delivering life-changing therapies in an inclusive environment.