Gilead Sciences · 5 hours ago
Director, R&D Quality Business Partners
United States
Full-time
Remote
Director/Executive
$187K/yr - $242K/yr
12+ years exp
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Responsibilities
Serves as the Quality Business Partner lead for assigned Gilead R&D functions, programs and/or vendors. Handles multiple projects simultaneously and ensures overall and timely completion of tasks.
Works closely with business and/or vendor teams to provide expert quality information, manage identified issues, and support continuous improvement.
Acts as Subject Matter Expert performing global risk assessment for all activities performed by assigned functions, vendors or relevant to assigned R&D programs.
Collaborates with the Audit, Inspection and CAPA Management Team within R&D Quality & Medical Governance on all internal quality audits, regulatory agency inspections, risk assessment, deviations and CAPA activities.
Assists in readiness preparation, and/or directly supports regulatory agency inspection. Assists in coordination of responses to any findings.
Supports deviation identification, reporting, and CAPA development.
Leads intra/inter-departmental teams that support operations (e.g., evaluation of new regulations and potential implications for Gilead R&D and/or R&D vendors).
Evaluates, writes and/or reviews standard operating procedures, and performs other activities in support of an integrated cross-functional QMS.
Collaborates with other R&D Quality and Medical Governance teams to ensure assigned functions, programs or vendors have timely and robust support for quality data/ analytics and reporting, quality documentation and training, quality technology and systems validation, and other related activities.
Fosters a commitment to quality in individuals and a culture of quality across Gilead R&D and with R&D vendors.
Provides matrix management and leadership to project teams.
Provides accurate and thorough input and recommendations into resource plans required to complete team deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.
Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
Qualification
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Required
PharmD/PhD with 8+ years’ experience.
MA/MS/MBA with 10+ years’ relevant experience.
BA/BS with 12+ years’ relevant experience.
Extensive experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and continuous improvement.
Experience working across a broad spectrum of quality and/or compliance activities, including authoring and reviewing SOPs, conducting internal auditing, supporting regulatory inspections, developing and managing CAPAs and deviations, and training others on quality and/or compliance requirements.
Extensive experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.
Proven track record of effective people leadership and management, as evidenced through past effectiveness with employee engagement, development and retention either with direct reports or through matrix leadership responsibilities.
Expert knowledge of the drug development process and GxP, including worldwide regulations and their application to cross-functional drug development.
Expert knowledge of all key functions involved in the various stages of drug development from early research through post-marketing.
Thorough knowledge of standards, systems, policies and procedures that enable QMS operations and compliance within the biopharma industry, including Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP), Good Pharmacovigilance (GVP) and Electronic Systems Compliance (ESC).
Proven abilities to assume increasing scope and complexity, as evidenced by past successes with team and project leadership, strategic cross-functional partnering, and key contributions to strategy, operational and infrastructure development.
Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
Strong interpersonal skills and understanding of team dynamics.
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.
Strong negotiation and conflict resolution skills.
Strong coaching capabilities to mentor/develop staff.
When needed, ability to travel.
Preferred
Experience working with total quality management methodologies, such as Lean Six Sigma.
Proven track record of successfully managing large scale, complex, time-sensitive projects.
Benefits
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10,001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (163)
2022 (216)
2021 (218)
2020 (226)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
2017-10-23IPO· bit:GILD
Leadership Team
Patrick Loerch
Senior Vice President, Clinical Data Science
Ahmed Afifi
Vice President - Region Head Latin America
Recent News
Business Wire
2024-11-14
Company data provided by crunchbase
