Director, R&D Quality Inspection Management
Director, R&D Quality Inspection Management
Apply locations United Kingdom - Cambridge posted on Posted 30+ Days Ago job requisition id R0042492
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.
Job Description
POSITION OVERVIEW:
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.
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:
* May serve as business process owner of inspection management in R&D.
* 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.
* Collaborates and proactively engages cross-functionally to gather and analyze risks and establish mitigations.
* Develops and delivers inspection specific GxP training for the R&D organization.
* Builds relationships and a network of cross-functional stakeholders to promote and enhance inspection readiness.
* Contributes to generation and continuous improvement of Gilead R&D inspection preparation tools.
* Prepares and leads instructor led training of Gilead R&D personnel in preparation for regulatory agency inspections.
* Leads and/or advises Subject Matter Experts on responses to regulatory agency inquiries and inspections.
* Analyses, consolidates and integrates prior Gilead and external intelligence to shape Gilead R&D inspection readiness.
* Coordinates inspection management horizon scanning, tracking and archiving activities.
* Contributes to metric generation and analysis across inspections.
* Drives for Veeva QMS record development on all inspection findings and action plans.
GxP Regulatory Compliance, Intelligence & Change Management:
* Supports development and execution of a compliance (GxP) intelligence change management program.
* Mines, analyzes, evaluates and escalates potential risks associated with emerging intelligence.
* Evaluates SOPs, other procedures, data and reporting of assigned R&D groups / locations.
* Contributes to a GxP external engagement program and knowledge management hub.
* Serves as point of contact and R&D Quality voice on external consortiums or compliance working groups.
* Leads and advises on continuous improvements to R&D inspection management processes.
Leadership:
* Provides collaborative matrixed leadership to project and inspection teams.
* Typically leads and manages direct reports, setting clear and elevating goals for the team.
* Ensures own work, and that of direct reports, complies with established practices, policies and processes.
* Fosters a commitment to quality in individuals and a culture of quality across Gilead R&D.
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Education & Experience
* BA/BS or advanced degree in life sciences or related field with significant relevant experience in the biopharma industry.
* Significant experience advising business functions in the biopharma industry on quality and compliance requirements.
* Significant experience in inspection management in the biopharma industry.
* Proven track record of effective people leadership and management.
* Experience participating or leading external consortiums, trade associations, professional bodies or industry groups.
* Proven track record of successfully managing large scale, complex, time-sensitive projects.
* Hands on experience leading cross-functional process improvement initiatives.
* Experience working for a global health authority is considered advantageous.
Knowledge & Other Requirements
* Significant knowledge of the biopharma industry.
* Expert knowledge of the drug development process and GxP requirements.
* Thorough knowledge of standards, systems, policies and procedures that enable QMS operations.
* Demonstrates strong strategic and analytical skills.
* Strong leadership presence with demonstrated ability to lead without authority.
* Strong communication and organizational skills.
* Strong coaching capabilities to mentor/develop staff.
* When needed, ability to travel.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company.
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