Senior Manager, Global Development Quality Assurance (GCP)

Responsibilities

• Manage, hire and develop direct reports by meeting with direct reports at least monthly and conducting performance assessments.
• Responsible for the training, resourcing, and individual staff development.
• Schedule, prepare, conduct, report, and follow-up on audits in support of routine and directed GxP audits as needed and in accordance with our standard operating procedures and quality policies.
• Audits include internal audits and external audits conducted globally.
• Represent the department by providing audit and compliance input in cross-functional meetings.
• Lead the identification of internal quality/compliance issues and act as a catalyst for process improvements to promote standardization and best practices.
• Interpret and may assist in developing policies and standards, and evaluate potentially critical problems not covered by policies, standards, and regulations.
• Provides education and/or training to GDQA and other relevant Global Development departments.
• May participate in regulatory inspections by acting as part of the control and/or inspection room team

Requirements

• Bachelors Degree (Masters degree preferred) with 8+ years of relevant industry experience.
• Deep knowledge of the FDA and EU regulations and ICH guidance documents along with any other regulations that may affect drug development and/or post-authorization safety monitoring.
• 5+ years of both direct people management and GCP audit experience preferred.
• Excellent communication and people management skills and ability to work with people in all levels of the organization and externally.
• Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.

Qualifications

• Strong leadership with demonstrated ability to collaborate with both direct reports and senior leaders.
• Good problem solving, written and verbal communication skills and uses professional concepts to evaluate problems and develop solutions for critical issues.
• Strong track record of project management, partner management, collaboration skills and negotiation of complex situations.