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Director, Quality Business Partner, Patient Safety

Company

Gilead Sciences
Address , Morris Plains, Nj
Employment type FULL_TIME
Salary $181,645 - $235,070 a year
Expires 2023-08-01
Posted at 11 months ago
Job Description
For Current Gilead Employees and Contractors:
Please log onto your
Internal Career Site
to apply for this job.
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

You will act as the R&D Quality Business Partner to the Patient Safety organization. You will provide strategic, expert advice and consultation on R&D quality, risk and continuous improvement with impact across cross-functional Good Practices (GxP). You will educate assigned groups on Gilead quality policy and procedural standards, GxP regulations and other requirements. You will provide expert advice on GxP risk minimization and mitigation. You will help business and vendor partners understand potential impacts of risk and alternatives to best address risk. You will also provide leadership support in escalating quality risks or issues. You will participate in and/or lead Quality forums, cross-functional teams and/or projects. You will act as the central point of contact for QMS-related communications to assigned groups; consolidating and channeling just-in-time information and resources to assist assigned groups. You will collaborate with other R&D Quality and Medical Governance groups to ensure just-in-time support and resources to assigned groups, including - data, reporting, training, audit, inspection, risk assessment and deviation/ CAPA management support. You may represent Gilead in regulatory inspections. Where applicable, you will play a lead role in R&D vendor selection, on-boarding, relationship management and governance. You may lead special projects that advance the capabilities of multiple team members across R&D Quality Business Partners. You may be a standing member of the overall R&D Quality and Medical Governance Extended Leadership Team with responsibilities for helping build and shape capabilities, and short- and long-range infrastructure across the overall R&D Quality and Medical Governance organization.
EXAMPLE RESPONSIBILITIES:
  • May have one or more direct reports
  • Evaluates, writes and/or reviews standard operating procedures, and performs other activities in support of an integrated cross-functional QMS.
  • Supports deviation identification, reporting, and CAPA development.
  • Fosters a commitment to quality in individuals and a culture of quality across Gilead R&D and with R&D vendors.
  • 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).
  • Assists in readiness preparation, and/or directly supports regulatory agency inspection. Assists in coordination of responses to any findings.
  • 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.
  • 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.
  • Acts as Subject Matter Expert performing global risk assessment for all activities performed by assigned functions, vendors or relevant to assigned R&D programs.
  • 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.
  • Works closely with business and/or vendor teams to provide expert quality information, manage identified issues, and support continuous improvement.
  • Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
  • 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.
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.
U.S. Education & Experience
  • 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.
  • Experience working with total quality management methodologies, such as Lean Six Sigma, is preferred.
  • BA/BS with 12+ years’ relevant experience.
  • MA/MS/MBA with 10+ 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.
  • Proven track record of successfully managing large scale, complex, time-sensitive projects.
  • PharmD/PhD with 8+ years’ experience.
  • 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.
Rest of World Education & Experience
BA/BS or advanced degree in life sciences or related field with extensive experience in the biopharma industry, including extensive experience working in quality, compliance or a related field.
Knowledge & Other Requirements
  • Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
  • Strong negotiation and conflict resolution skills.
  • Strong coaching capabilities to mentor/develop staff.
  • Expert knowledge of the drug development process and GxP, including worldwide regulations and their application to cross-functional drug development.
  • When needed, ability to travel.
  • 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).
  • Expert knowledge of all key functions involved in the various stages of drug development from early research through post-marketing.
  • 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 interpersonal skills and understanding of team dynamics.
  • 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.

The salary range for this position is: $181,645.00 - $235,070.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
  • Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:
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 or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections, please view the
'Know Your Rights'
poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:
Please log onto your
Internal Career Site
to apply for this job.