The Associate Director, Patient Service Center (PSC) Operations is responsible for leading a team to deliver efficient, compliant, and high-quality services to patients and providers across patient support programs. This role ensures operational excellence, regulatory compliance, and continuous improvement in all program activities.
Locations (8)
Charlotte, North Carolina, United States
Dallas, Texas, United States
Horsham, Pennsylvania, United States
Orlando, Florida, United States
Phoenix, Arizona, United States
Pittsburgh, Pennsylvania, United States
Show all 8 locations
Raleigh, North Carolina, United States
Titusville, New Jersey, United States
Compensation
anticipated base pay range for this position is $127,000.00 - $218,500.00
Responsibilities
Lead, mentor, and motivate team members to achieve performance goals and high customer satisfaction.
Oversee day-to-day operations, ensuring adherence to policies, procedures, and service level agreements (SLAs).
Monitor key performance indicators (KPIs) and identify areas for operational improvement.
Ensure all operations follow industry regulations and company standards.
Analyze customer feedback to drive service enhancements and resolve issues.
Field-based senior leadership role focused on the Oncology Lung and Head Neck cancer portfolio, driving district strategy, talent development, and cross-functional partnership.
Director of Corporate Development responsible for identifying, evaluating, and executing external opportunities aligned with Gilead’s R&D Oncology strategies.
Responsibilities
Proactively identify, engage with, and evaluate external opportunities aligned with Gilead’s R&D Oncology strategies
Work directly with Gilead’s Competitive Intelligence group to understand therapeutic area landscapes, inflection points of key clinical stage programs, and define competitive landscapes for targets/programs of interest
Present new opportunity summaries and recommendations to therapeutic area leadership at regular triage meetings
Oversee and guide cross‑functional scientific diligence teams assembled to evaluate selected opportunities and summarize overall assessments and recommendations
Work in partnership with transaction colleagues in Corporate Development and cross‑functional diligence teams to prepare and present opportunity proposals to Senior Leadership governance committees for approval
Requirements
Bachelor’s degree
Master’s Degree
PhD/PharmD/DVM/MD or similar life sciences education
Summary
The CQV Specialist ensures the control, compliance, availability, and integrity of all documentation subject to GMP requirements in order to maintain site regulatory compliance and operational traceability. They check that all quality-related documents are created, reviewed, approved, distributed, and archived in accordance with applicable procedures.
Duties and responsibilities
Quality Master Plan Documentation - Draft and maintain:
Draft and maintain:
Standard Operating Procedures (SOPs)
Work Instructions
Internal « Quality Master Plan » updates
« Project Validation Plan » updates
« Change Control Management » procedure
Project-Specific GMP Documentation
Prepare project-specific quality documentation
FAT, SAT, IQ, and OQ protocols
Support to Project Managers During FAT & SAT Activities
Prepare FAT activities and pre-testing
Support the Project Manager during FAT execution
Follow up on non-conformities
Prepare qualification reports
Additional Responsibilities
Deliver GMP and GDP training and awareness activities
Support the preparation of internal and external audit
Rédaction de documents du « Quality Master Plan » :
Procédure de travail (SOP)
Instruction de travail
Mise à jour du « Quality Master Plan » interne
Mise à jour du « Project Validation Plan »
Procédure de « Change Control Managment»
Rédaction de la documentation GMP spécifique projet:
Rédaction du plan de qualité spécifique à un projet
Réalisation des protocoles FAT/SAT/IQ/OQ
Assistance aux responsables de projets durant les FAT&SAT :
Préparation de la FAT et des tests préliminaires
Accompagnement du responsable de projet durant la FAT
Suivi des non-conformités
Rapport de qualification
Tâches annexes et supplémentaires
Formation et sensibilisation pour GMP et GDP
Préparer les audits internes et externes
Required Experience
Minimum 5 years of experience in GMP documentation, validation, quality assurance, or a regulated pharmaceutical/biotech/medical device environment.
Experience creating and managing GMP documentation (SOPs, protocols, reports, validation plans, quality plans).
Experience supporting FAT, SAT, IQ, and OQ activities.
Experience working within Change Control, Deviation, CAPA, and Document Management systems.
Experience supporting internal and external audits and regulatory inspections.
Skills & Competencies
Strong knowledge of GMP, GDP, and validation requirements.
Excellent technical writing and document control skills.
Ability to review, organize, and maintain complex documentation packages.
Strong attention to detail and compliance mindset.
Effective communication and collaboration with Quality, Engineering, Automation, and Project Management teams.
Strong organizational and prioritization capabilities.
Problem-solving and root cause analysis skills.
Ability to work independently while managing multiple projects and deadlines.
Languages
English: Professional working proficiency (required)
French: fluent (required)
Key Performance Indicators (KPIs)
On-time completion of GMP documentation deliverables.
Percentage of documentation approved without major rework.
Closure rate of documentation review comments.
Timely completion of FAT/SAT/IQ/OQ/PQ documentation packages.
Number of overdue documentation actions.
Audit observations related to documentation compliance.
Change Control documentation closure performance.
Reduction in documentation errors, deviations, or recurring compliance observations.
Audit findings closure rate.
Translate enterprise and regional direction into district strategy with clear priorities, measurable outcomes, and disciplined execution.
Drive district performance across the Lung and Head Neck Cancer portfolio, including RYBREVANT and LAZCLUZE.
Lead and develop a high-performing team through hiring excellence, performance management, and development planning.
Provide advanced coaching and mentoring that strengthens selling effectiveness, clinical execution using approved resources, and business acumen across the team.
Drive demand generation and care transitions execution across outpatient and inpatient settings.
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