Senior QA Manager

Job summary

The Senior QA Manager will oversee GLP quality assurance within the non-clinical development program, while also developing expertise in GCP and clinical trial quality oversight. This role focuses on conducting audits at contract research laboratories and supporting GCP audits as part of a risk-based quality assurance approach.

Qualifications

• Extensive hands-on GLP auditing experience, including study and facility audits, in a pharmaceutical or biotechnology environment.
• Strong understanding of OECD GLP Principles and/or FDA 21 CFR Part 58.
• Familiarity with computerized system requirements (21 CFR Part 11, ICH E6(R3), GAMP5) is beneficial.
• GCP experience in clinical QA or audit roles is advantageous but not mandatory.
• Experience in managing quality events, deviations, CAPAs, and change control in a regulated setting.
• Experience supporting regulatory inspections is a plus.

Responsibilities

• Develop and implement a risk-based audit program for GLP test facilities and GCP service providers.
• Conduct GLP audits, assessing data integrity and compliance at contract research laboratories.
• Provide support for GCP audits at clinical trial service providers while building GCP expertise.
• Advise clinical trial teams on protocol compliance and oversight of service providers.
• Manage quality events related to GCP activities, ensuring timely root cause analysis.
• Establish and maintain QA relationships and oversight plans with service providers and laboratories.

Skills

• Strong analytical and problem-solving skills with a pragmatic approach to quality assurance.
• Ability to translate compliance requirements into practical solutions.
• Team-oriented mindset with a focus on collaboration and communication.

Education

• Relevant degree in a scientific or quality assurance field is preferred.

Tools

• Familiarity with quality management systems and computerized systems relevant to GLP and GCP.