Director, R&D Quality, Inspection Management

Role Summary

Director, R&D Quality, Inspection Management leads the development and maintenance of a framework to improve inspection management, supporting readiness for GCP, GLP/GCLP and GPV inspections by regulatory authorities. The role serves as the primary point-of-contact for R&D Quality inspection management and represents Gilead in regulatory inspections, collaborating cross-functionally to ensure ongoing regulatory compliance under the Quality Management System. The director develops short- and long-range inspection management strategy and may have direct reports, leading special projects to advance the capabilities of the R&D Quality Inspection Management group.

Responsibilities

• 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.
• People Leader Accountabilities: Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• People Leader Accountabilities: Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• People Leader Accountabilities: Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

Qualifications

• Required: 12+ years of relevant experience with a BS or 10+ years of relevant experience with an MS.
• Required: Must have relevant work experience within a pharmaceutical quality control, quality assurance or compliance environment.
• Preferred: Recognized as a knowledgeable resource within the department and from other departments on a range of topics and someone whose opinion is sought as a regulatory resource.