Director, R&D Quality, Inspection Management

Director, R&D Quality, Inspection Management

Location:

Sunnyvale, California.

Employment type:

Full-time.

You will act as a primary point-of-contact for R&D Quality inspection management and act as an inspection readiness ambassador, supporting the drive to a continuous improvement company culture. You will lead development and maintenance of a comprehensive and connected framework for continually improving inspection management, supporting R&D personnel with the readiness, preparation, conduct and follow‑up for GCP, GLP/GCLP and GPV inspections by regulatory health authorities.

You will typically represent Gilead in regulatory inspections as a lead representative and point-of-contact for regulatory agencies. You will collaborate cross‑functionally to ensure Gilead's ongoing regulatory compliance and R&D GxP quality operations in accordance with Gilead's Quality Management System (QMS) and related policies and procedures. You will play a role in development and maintenance of an intelligence change management system and framework.

You will typically play a key role in developing the short‑ and long‑range R&D inspections management strategy, infrastructure and resource plans. You may also support senior colleagues in R&D Quality Inspection Management. You may have one or more direct reports. You will also play a leadership role in special projects that advance the capabilities and/or resources of the overall R&D Quality Inspection Management group and/or the wider R&D Quality organization.

• Lead efforts to increase the commitment to quality in individuals and a culture of quality within the organization.
• Area of responsibility may be limited to Clinical Compliance, Laboratory Compliance, or Electronic Systems Compliance.
• Work is performed under consultative direction towards corporate and department goals and objectives. Ensures that tools are appropriate and fit for purpose.
• Supervise the coordination of the work of others.
• Ensures annual audit plans are developed and audit activities are completed according to plan across sites and monitors resources and budget for audits.
• Identifies new contract auditors, oversees the establishment of agreements and ensures all commitments are met by contract auditors.
• Responsible for the oversight of SOPs evaluation and implementation.
• Keeps a watch toward changes in industry/regulatory environment that would necessitate future changes and proactively initiates discussions so the company is prepared to respond to such changes.
• Contributes to or leads intra‑ or interdepartmental teams of a strategic nature such as: defining the direction of the Company in response to industry or regulatory initiatives, implementing company‑wide Quality Management or computer systems.
• May lead management of regulatory agency inspections and coordination of responses to any regulatory agency findings.
• Anticipates training requirements based on business needs and evolving regulatory environment.
• May lead change projects which have strategic impact on the organization and act as a role model for change by demonstrating commitment.
• Direct others in prioritizing their work and assists in developing strategic plans for business areas that contribute to organizational goal.
• Contributes to establishing Compliance quality standards.
• Builds positive support for position outside of formal meetings.
• Determines most efficient and appropriate method of communication in a variety of situations.
• Understands impact of decisions and actions on business and consults with appropriate colleagues and management.
• Promotes and maintains productive working relationships and mentors others in establishing good working relationships.
• Demonstrates highly developed knowledge of regulatory requirements for assigned territories.
• Understands current global and regional trends in regulatory compliance and ability to assess the impact of these requirements to the business.

• 12+ years of relevant experience and a BS.
• 10+ years of relevant experience and an MS.
• Must have relevant work experience within a pharmaceutical quality control, quality assurance or compliance environment.