Director, R&D Quality, Inspection Management
United States - California - Foster CityQualityRegularDescripción del trabajo
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.
Please note: this position is based in Foster City, CA with no relocation, local candidates are encouraged to apply.
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.
As a Director, R&D Quality, Inspection Management, at Gilead you will ...
Key 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.
Basic Qualifications:
- 12+ years of relevant experience and a BS OR
- 10+ years of relevant experience and an MS.
- Must have relevant work experience within a pharmaceutical quality control, quality assurance or compliance environment.
Preferred Qualifications:
- 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.