Sr Director, Pharma Technology and Systems (Remote)

The Senior Director, Pharma Technology and Systems is a key business leader responsible for technology and systems strategy and implementation within our Pharma Services BU. The successful candidate will partner with internal teams and external vendors to identify and develop system requirements and evaluate existing products that meet business needs. The Senior Director will lead and manage regulatory compliance for technology and systems used in the Pharma business, and will also be responsible for aligning Pharma’s business and technology needs with corporate technology strategy.

• Partner with business to identify and define technology enablers that will support business strategy through next 3-5 years.
• Collaborate with corporate IT on business and technology strategy to deliver solutions that enable pharma business growth objectives.
• Oversee and manage internal teams and external vendors to develop, validate, and deploy technology solutions.
• Develop and oversee Computer System Validation program and deploy against relevant systems. Create Part 11 program including performing gap assessments against existing systems.
• Support audits and remediation efforts to deliver compliant processes and systems that will enable growth in the pharma services market.
• Manage team (internal and external) that oversees pharma specific tools and systems. This may include project managers, business analysts, programmers, testers, and technical writers. 
• Maintain compliance of pharma systems and technologies.
• Create SOPs, forms, and processes to provide and maintain compliant technology solutions.
• Present to senior leaders across Quest as a member of the pharma leadership team.
• Create reporting and analytics infrastructure to enable KPI monitoring for business performance.

Required Work Experience:

• Minimum 15-20 years in lab technology/IT management with experience in both CAP/CLIA and GxP environments including 21CFR Part11.  Experience building and managing LIMS, Patient Portal, and client portals.

Preferred Work Experience: 

• 20+ years experience, business strategy, startup/entrepreneurship, and central lab experience.  Proven ability to deliver results in a matrix in large corporations.

Knowledge: 

• Computer systems, programming, validation, regulatory, clinical and central laboratories

Skills:

• Technical/technology as well as regulatory knowledge

Education:
Bachelor’s Degree(Required)
Master’s Degree