Senior Director, Global Development Quality Assurance (GLP)

Role Summary

As a Senior Director, Global Development Quality Assurance (GDQA), you will provide leadership for the GLP function and lead all staff to execute the department's mission and vision. You will create and oversee strategic partnerships and implement risk-based quality auditing activities internally and with external organizations, applying expert knowledge of FDA and EU regulations, ICH guidance, and other regulations affecting drug development. This position is on-site 4 days per week at our Tarrytown, NY offices, with relocation benefits available for eligible candidates; remote work is not offered.

Responsibilities

• Developing and managing the overall strategic plan for the GLP audit functions.
• Represent the GDQA audit function by providing audit and compliance input in cross functional meetings and external meetings.
• Manage, hire and develop direct reports within GDQA and conducting Mid-year and End-of year performance assessments.
• Lead the identification of internal quality/compliance issues and act as a catalyst for process improvements to promote standardization and best practices.
• Represent GDQA on top priority teams, complex compliance projects and initiatives both within and across functional areas or other departments as applicable.
• Be responsible for policies, standards, and regulations, and evaluate potentially critical problems.
• Oversee the education and/or training of the GDQA organization and other Global Development departments as needed.
• Ensure succession planning and business continuity for GDQA department.

Qualifications

• 12+ years of relevant industry experience required; minimum 10 years’ experience in GLP auditing and/or audit strategy and 6-8 years of supervisory/leadership experience.
• Strong knowledge of FDA or other regulatory inspections of Investigator sites, Sponsors or CROs.
• Demonstrated experience in driving quality into the Clinical Trial Operations processes.
• Can demonstrate success in leading a GLP Quality Assurance (GDQA) function.
• Self-motivated with the ability to work effectively in a dynamic environment with ambiguity.
• Ability to effectively manage multiple priorities with a sense of urgency.

Education

• Bachelor’s degree required; Master’s degree preferred.

Skills

• Leadership and people management
• Project management and cross-functional collaboration
• Negotiation of complex situations