Easter Seals Jobs

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

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

You will act as the R&D Quality Business Partner to assigned groups, such as Gilead R&D functions or vendors supporting Gilead R&D. You will provide strategic, expert advice and consultation on R&D quality, risk and continuous improvement with impact across cross-functional Good Practices. You will educate assigned groups on Gilead quality policy and procedural standards, GxP regulations and other requirements. You will provide expert advice specifically on GCLP 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 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 qualification, on-boarding, relationship management and governance. You may provide GCLP/GLP support for company integrations, as applicable.

EXAMPLE RESPONSIBILITIES:

• May serve as the Quality Business Partner lead for assigned Gilead R&D groups, teams, workstreams, or projects.

• As assigned, supports QBP leads with a range of preparatory, preliminary, and follow-up activities, such as research, analysis, logistical or preliminary preparation, documentation, reporting, conducting risk assessments, addressing quality deviations, developing CAPAs, preparing for audits and inspections, and other activities.

• Works closely with business and/or vendor teams to provide quality information, manage identified issues, and support continuous improvement.

• Acts as Subject Matter Expert performing risk assessment for assigned activities.

• Collaborates with the Audit, Inspection and CAPA Management Team within R&D Quality & Medical Governance on internal quality audits, regulatory agency inspections, risk assessment, deviations and CAPA activities.

• Support company integration related activities for GCLP/GLP and related vendors

• Assists in readiness preparation for regulatory agency inspection. May assist in coordination of responses to any findings.

• Supports deviation identification, reporting, and CAPA development.

• Participates in 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).

• May prepare preliminary analysis and development of 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.

• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

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

• PharmD/PhD with 0+ years’ experience. PharmD/PhD with 2+ years’ experience is preferred.

• MA/MS/MBA with 6+ years’ relevant experience.

• BA/BS with 8+ years’ relevant experience.

• •Significant experience working with GxP processes and systems in the biopharma or related industry is strongly preferred. Experience with R&D vendor management is preferred. Experience working with total quality management methodologies, such as Lean Six Sigma, is preferred.

• Experience working with one or more Gilead therapeutic areas and varying stages of drug development is a plus.

Rest of World 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 quality, compliance or a related field.

Knowledge & Other Requirements

• Advanced knowledge of the drug development process and understanding of and appropriate application of principles, concepts, practices, and cross-disciplinary GxP standards, as evidenced by ability to independently identify potential quality and compliance issues and recommend appropriate remediations.

• Demonstrates ability to analyze and resolve complex problems collaboratively with cross-functional colleagues, including ability to assess GxP processes and systems and understand the quality and compliance implications. Strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through abilities to assume assignments and projects with increasing independence.

• Ability to lead and influence programs, projects and/or initiatives.

• Strong interpersonal skills and understanding of team dynamics.

• Proven ability to work successfully in a team-oriented, highly matrixed environment.

• When needed, ability to travel.

The salary range for this position is: $154,020.00 - $199,320.00. 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 ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.