Gilead Sciences, Inc.
Director, R&D Quality Inspection Management
Gilead Sciences, Inc., Foster City, California, United States, 94420
Director, R&D Quality Inspection ManagementLocations: United States - California - Foster City, United States – Remote, United States - New Jersey - Parsippany
Time Type: Full time
Job Requisition ID: R0043180
Job Description
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.
EXAMPLE RESPONSIBILITIES:
Responsible for the effective management, execution and oversight of R&D inspection activities and deliverables, including but not limited to, establishing standards and processes for defining inspection readiness, the preparation and conduct of inspections, the integration of lessons learned into preparation and the continuous scanning, assessment and implementation of regulatory changes.
Inspection Readiness, Preparation, Conduct & Close-out:
Leads all designated operational, managerial and administrative activities within R&D Quality Inspection Management.
Supports global Gilead R&D inspection readiness, in partnership with the Quality Business Partners and functional area leads, by advising on Gilead practices, procedures, systems and other tools.
Collaborates and proactively engages cross-functionally to gather and analyze risks and establish mitigations, as well as support remediation where needed.
Develops and delivers inspection specific GxP training for the R&D organization (including playbooks and responsibility matrices).
Builds relationships and a network of cross-functional stakeholders to promote and enhance inspection readiness.
Leads and/or advises Subject Matter Experts on responses to regulatory agency inquiries and inspections, as necessary coordinating a united company response, in conjunction with the Inspection Leads and Inspection Sponsor(s).
Drives for Veeva QMS record development on all inspection findings and action plans, including commitment follow-up and oversight.
GxP Regulatory Compliance, Intelligence & Change Management:
Supports development and execution of a compliance (GxP) intelligence change management program and operating framework.
Evaluates SOPs, other procedures, data and reporting of assigned R&D groups / locations to ensure ongoing regulatory compliance, R&D quality and fit-for-purpose to both Gilead business needs and changing regulatory requirements.
Contributes to a GxP external engagement program and knowledge management hub to monitor and track Development’s engagement with external groups and conferences.
Leads and advises on continuous improvements to R&D inspection management processes, procedures, practices and tools.
Leadership:
Provides collaborative matrixed leadership to project and inspection teams.
Typically leads and manages direct reports, ensuring delivery against objectives.
Fosters a commitment to quality in individuals and a culture of quality across Gilead R&D and with R&D vendors.
REQUIREMENTS:
PharmD/PhD with 8+ years’ relevant experience or MA/MS/MBA with 10+ years’ relevant experience or BA/BS with 12+ years’ relevant experience.
Significant experience advising business functions in the biopharma industry on quality and compliance requirements.
Proven track record of effective people leadership and management.
Experience participating or leading external consortiums, trade associations, professional bodies or industry groups.
Hands on experience leading cross-functional process improvement initiatives.
Knowledge & Other Requirements:
Expert knowledge of the drug development process and GxP requirements.
Strong strategic and analytical skills.
Strong interpersonal skills and understanding of team dynamics.
Strong communication and organizational skills.
Strong coaching capabilities to mentor/develop staff.
The salary range for this position is: $205,700.00 - $266,200.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package.
For additional benefits information, visit:
Gilead Benefits
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics.
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Time Type: Full time
Job Requisition ID: R0043180
Job Description
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.
EXAMPLE RESPONSIBILITIES:
Responsible for the effective management, execution and oversight of R&D inspection activities and deliverables, including but not limited to, establishing standards and processes for defining inspection readiness, the preparation and conduct of inspections, the integration of lessons learned into preparation and the continuous scanning, assessment and implementation of regulatory changes.
Inspection Readiness, Preparation, Conduct & Close-out:
Leads all designated operational, managerial and administrative activities within R&D Quality Inspection Management.
Supports global Gilead R&D inspection readiness, in partnership with the Quality Business Partners and functional area leads, by advising on Gilead practices, procedures, systems and other tools.
Collaborates and proactively engages cross-functionally to gather and analyze risks and establish mitigations, as well as support remediation where needed.
Develops and delivers inspection specific GxP training for the R&D organization (including playbooks and responsibility matrices).
Builds relationships and a network of cross-functional stakeholders to promote and enhance inspection readiness.
Leads and/or advises Subject Matter Experts on responses to regulatory agency inquiries and inspections, as necessary coordinating a united company response, in conjunction with the Inspection Leads and Inspection Sponsor(s).
Drives for Veeva QMS record development on all inspection findings and action plans, including commitment follow-up and oversight.
GxP Regulatory Compliance, Intelligence & Change Management:
Supports development and execution of a compliance (GxP) intelligence change management program and operating framework.
Evaluates SOPs, other procedures, data and reporting of assigned R&D groups / locations to ensure ongoing regulatory compliance, R&D quality and fit-for-purpose to both Gilead business needs and changing regulatory requirements.
Contributes to a GxP external engagement program and knowledge management hub to monitor and track Development’s engagement with external groups and conferences.
Leads and advises on continuous improvements to R&D inspection management processes, procedures, practices and tools.
Leadership:
Provides collaborative matrixed leadership to project and inspection teams.
Typically leads and manages direct reports, ensuring delivery against objectives.
Fosters a commitment to quality in individuals and a culture of quality across Gilead R&D and with R&D vendors.
REQUIREMENTS:
PharmD/PhD with 8+ years’ relevant experience or MA/MS/MBA with 10+ years’ relevant experience or BA/BS with 12+ years’ relevant experience.
Significant experience advising business functions in the biopharma industry on quality and compliance requirements.
Proven track record of effective people leadership and management.
Experience participating or leading external consortiums, trade associations, professional bodies or industry groups.
Hands on experience leading cross-functional process improvement initiatives.
Knowledge & Other Requirements:
Expert knowledge of the drug development process and GxP requirements.
Strong strategic and analytical skills.
Strong interpersonal skills and understanding of team dynamics.
Strong communication and organizational skills.
Strong coaching capabilities to mentor/develop staff.
The salary range for this position is: $205,700.00 - $266,200.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package.
For additional benefits information, visit:
Gilead Benefits
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics.
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