Quality Lead

• Serves as Quality Business Partner lead for assigned Client R&D functions, programs and/or vendors. Handles multiple projects simultaneously and ensures overall and timely completion of tasks.

• Works closely with business to provide expert quality information, manage identified issues, and support continuous improvement.

• Acts as Subject Matter Expert supporting GCP cross portfolio risk assessment for all activities performed by assigned functions, vendors or relevant to assigned R&D programs.

• Collaborates with the Audit, Inspection and CAPA Management Team within R&D Quality as required on internal quality audits, regulatory agency inspections, risk assessment, deviations and CAPA activities.

• Assists in readiness preparation, and/or directly supports regulatory agency inspection.

• Supports deviation identification, reporting, and CAPA development.

• Supports evaluation of new regulations and potential implications for Client R&D and/or R&D vendors.

• Evaluates, writes and/or reviews standard operating procedures, and performs other activities in support of an integrated cross-functional QMS.

• Collaborates with other R&D Quality teams to ensure assigned functions, programs or vendors have timely and robust support for quality data/ analytics and reporting, quality documentation and training, quality technology and systems validation, and other related activities.

• May lead or support projects.

• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

REQUIREMENTS:

Education & Experience

• PharmD/PhD with 2+ years’ experience.

• MA/MS/MBA with 8+ years’ relevant experience.

• BA/BS with 10+ years’ relevant experience.