Senior Director, Global Development Quality Assurance (GLP)

As a Senior Director, Global Development Quality Assurance (GDQA) you will provide leadership for an entire GLP function. You will lead all staff while developing and leading all aspects of the execution of functional/departmental mission and vision. You will create and oversee strategic partnerships and implement risk-based quality auditing activities internally and with external organizations. You are expect to apply your expert knowledge of the FDA and EU regulations and ICH guidance documents with other regulations affecting drug development. 

You will manage Good Laboratory (GLP) audit function within GDQA. In addition, we partner with other members of the GDQA, identifying trends through metrics to diagnose and remediate systemic quality issues. We oversee the development, execution and reporting of the overall GxP Audit Program(s) for which they are responsible. 

This position will be on-site 4 days/week at our Tarrytown, NY offices. We cannot offer a remote option. If eligible, we can offer relocation benefits. 

A typical day may include the following: 
•    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.

This may be for you if you: 
•    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 
•    Strong people and project management, collaboration skills and negotiation of complex situations 

To be considered a Bachelor’s degree (Master’s preferred) with 12+ years of relevant industry experience is required. We are seeking a minimum of 10 years’ experience working in GLP auditing and/or audit strategy and 6-8 years prior supervisory/leadership experience. Strong knowledge of FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs is necessary. Demonstrated experience in driving Quality into the Clinical Trial Operations processes. 
 

$216,100.00 - $360,200.00