Director, Intelligence Compliance & Quality Integration Management

Director, Intelligence Compliance & Quality Integration Management

Director, Intelligence Compliance & Quality Integration ManagementUnited Kingdom - Uxbridge Quality RegularJob Description

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. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

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. Join Gilead and help create possible, together.

Job Description

POSITION OVERVIEW:

In this role you will have two primary accountabilities with focus on health and evolution of the Gilead R&D Quality Management System (QMS): 1) drive intelligence change management activities, i.e. implementation of new legislation to ensure proactive compliance, and 2) serve as R&D Quality integration lead to facilitate effective integration with Gilead’s R&D QMS or enable QMS documentation to support collaborations. R&D Quality strategic objectives are focused on building and improving core capabilities and services related to Gilead’s QMS. These activities will span GLP, GCP, GVP requirements as well as core elements of our QMS such as Audits, Inspections, Vendor Quality, Reporting and Analytics, Documentation and Training, as well as supporting QMS systems and tools. Integration will focus on effectively transitioning external assets into the Gilead R&D QMS or enabling cross-company QMS interactions. You will play a role in development and maintenance of an intelligence change management system and framework and an integration framework and processes. As part of this role, you will interface with and work with various teams including but not limited to Clinical Development functions, Legal, Information Technology, Pharmaceutical Development and Manufacturing teams.

EXAMPLE RESPONSIBILITIES:

GxP Regulatory Compliance Intelligence:

• Support development and execution of a compliance (GxP) intelligence change management program and operating framework.
• Mine, analyze, evaluate and escalate potential risks associated with emerging intelligence.
• Lead the assigned R&D groups / locations in impact assessment and implementation planning for changes to regulations or other requirements and associated continuous improvement initiatives, including delivering the project goals on time and on-budget, while ensuring compliance.
• Evaluate 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.
• Contribute to a GxP external engagement program and knowledge management hub to monitor and track Development’s engagement with external groups and conferences as well as encouraging and facilitating presentations and creating a collective voice for Gilead GxP compliance.
• Serve as point of contact and R&D Quality voice on external consortiums or compliance working groups.
• Lead continuous improvement activities on R&D inspection management processes, procedures, practices and tools.
• Analyze inspection data, external industry intelligence and data (e.g. Redica), and regulations to assess Gilead gaps and opportunities and then build out project plans to help inform our inspection readiness and preparation activities and tools.
• Support inspection management team as required with inspection readiness, preparation and conduct activities.
• When needed, plan and scope GxP-related intelligence change management, including communication plans.
• Develop standard tools and method to provide regular updates to leadership / business.

QMS and Quality Integration Responsibilities:

• Create and maintain a central repository for relevant Gilead R&D integration documentation, tools and procedures.
• Develop applicable procedural documents and tools to support R&D Quality’s integration activities.
• Advise Development / Integration Management Office integration leads on Quality considerations for their functional areas to ensure compliance.
• Advise the business stakeholders on quality related activities in their functional areas as it relates to the integration.
• Coordinate periodic risk assessments on assets and integrations, including maintenance of integration risk registers.
• Develop standard templates for the various R&D Quality integration plans and reports.
• Develop standard templates such as Integration plans that may be used for R&D functions.
• Monitor state, lead, and/or coordinate the Quality deliverables for various integrations.
• Develop and maintain metrics to monitor compliance of integration activities and completion of deliverables.
• Ensure historical records are appropriately archived as part of integration.
• Coordinate with Due Diligence Lead for appropriate hand off once integration is initiated
• Facilitate lessons learned sessions, and update and maintain R&D Quality Integration Playbook with relevant business needs and the lessons learned.
• Ensure GxP-related project records are fully retrievable in the QMS for inspection purposes.
• Own and periodically review the QMS Manual to include changes in key processes and systems as it relates to Integrations.

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, including significant experience working in a quality or compliance field.
• Significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and continuous improvement.
• Significant experience working with and establishing strong relationships across R&D functions and external stakeholders.
• Experience participating or leading external consortiums, trade associations, professional bodies or industry groups.
• Demonstrated excellence in written and oral communication.
• Applied knowledge of performance measurements (e.g., metrics, dashboards).
• Proven ability to delegate in matrix environment, predict issues, anticipate risks and solve problems.
• Strong leadership presence with demonstrated ability to negotiate and lead without authority and influence programs, projects and/or initiatives.
• Strong EQ and interpersonal skills and with proven understanding of team dynamics.
• Proven track record of successfully managing large scale, complex, time-sensitive projects and process improvement initiatives with measurable outcomes.

Knowledge & Other Requirements

• Significant knowledge of the biopharma industry, as evidenced by proven track record in setting short- and long-range business strategies and plans.
• Expert knowledge of the drug development process and GxP requirements (i.e., clinical studies, post-marketing/pharmacovigilance, and labs).
• Thorough knowledge of standards, systems, policies and procedures that enable QMS operations, integrations and compliance within the biopharma GxP environment.
• Demonstrates strong strategic and analytical skills, with strengths in assessing complex information and understanding the quality and compliance implications.
• Proven abilities to anticipate problems of varying complexity and lead, and if necessary, negotiate, the resolution of these in a collaborative manner across functions.
• Proven understanding of tools, processes, and order of operations required to successfully complete projects.
• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives and unify various stakeholders with different backgrounds, strengths, and abilities.
• Strong interpersonal skills and understanding of team dynamics, enabling negotiation and conflict resolution skills.
• Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
• Ability to work independently, with high integrity and standards for outputs and deliverables.
• 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. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

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Job Requisition ID R0045134

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