- Responsible for the coordination and collection of data and information for Core Metrics and Quality Management Reviews.
- Analyze data and support stakeholders in the development of key messages and insights on risks or opportunities.
- Facilitate meetings with stakeholder parties to ensure alignment on metric definitions, calculations, and collection methods as required.
- Supports management review process through development and generation of quality system metrics and trending, and escalate issues as required.
- Supports the continuous improvement to the quality metrics and management review programs by gathering feedback and providing recommendations on tools, data, and processes.
- Writes and/or implements changes to SOPs and Quality Metrics catalog as needed.
- Maintains the schedule and milestones needed to support monthly and quarterly reviews.
- Responsible for communicating and presenting to executive leadership.
- Prioritize & accomplish multiple tasks in a fast-paced, deadline driven and detail-oriented work environment.
- Assist compliance audits as required.
- Works with teams to implement and enhance data analytics tools and data sets.
- Keep abreast of applicable regulations and emerging trends related to performance monitoring and metric reporting.
- Highly organized individual with a strong work ethic and ability to work effectively with many deadlines in a complex matrix organization.
- Experience with Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
- Experience with application of QA principles, concepts, industry practices, and standards.
- Experience with Quality Systems processes (Deviation, CAPA, Change Control, Audit, etc.)
- Demonstrates familiarity with industry standards and trends in life sciences
- Demonstrates strong verbal, technical writing, and interpersonal skills.
- Demonstrates proficiency in Microsoft Office applications, specifically Excel PowerPoint, and Teams.
- Familiarity with technology platforms such as Veeva Vault, SAP ERP, as well as Business Intelligence (BI) tools (e.g. AWS Quicksight).
- 5+ years of relevant experience in a GMP environment related field and a BS or BA.
- 3+ years of relevant experience and a MS.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
-
Program Manager, People Data Review
1 week ago
Meta Menlo Park, United StatesThe People Data Review Program Manager will join the People Risk, Privacy, Compliance (PRPC) team to work across our key partners to lead risk initiatives to scale our global program. Specifically, the People Data Review Program Manager will be responsible for leading end-to-end ...
-
Gilead Sciences Foster City, United StatesSenior Manager, Global Regulatory Operations Quality Review page is loaded · Senior Manager, Global Regulatory Operations Quality Review · Bewerben · locations · United States - California - Foster City · United States – Remote · time type · Full time · posted on · Vor 9 ...
-
Professional Diversity Network San Mateo, United States Full timeWorkday · Your work days are brighter here. · At Workday, it all began with a conversation over breakfast. When our founders met at a sunny California diner, they came up with an idea to revolutionize the enterprise software market. And when we began to rise, one thing that reall ...
-
Gilead Sciences San Mateo, United StatesSenior Manager, Global Regulatory Operations Quality Review · United States - California - Foster CityUnited States – Remote · Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet ...
-
Gilead Sciences Belmont, United StatesQuality Systems Specialist III, Quality Metrics and Management Review · United States - California - Foster City · Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need ...
-
Peer Review Manager
1 week ago
El Camino Hospital Mountain View, United StatesEl Camino Health is committed to hiring, retaining and growing the best and brightest professionals who will carry our mission and vision forward. We are proud of our reputation in the community: One built on compassion, innovation, collaboration and delivering high-quality care. ...
-
Director, Revenue
1 week ago
Qualys Foster City, United StatesCome work at a place where innovation and teamwork come together to support the most exciting missions in the world · Director, Revenue Accounting · The Director, Revenue Accounting will be responsible for managing the month-end close process for revenue. · Key Responsibilities i ...
-
Commercial Property Administrator
1 week ago
Harvest Properties Foster City, United States***: · This in-person role is responsible for all day-to-day, administrative, and accounting aspects necessary for the efficient operation and management of a portfolio of buildings including tenant/vendor relations, lease administration, accounts payable, accounts receivable, fi ...
-
Laboratory Operations
2 weeks ago
Gilead Sciences Foster City, United StatesThe LabOps Project Manager will oversee projects pertaining to the purchase, installation, and qualification of new analytical instrumentation, equipment, and software. This individual will work with project teams consisting of cross-functional team members from metrology, valida ...
-
Clinical Trial Manager
1 week ago
Fladger Associates Foster City, United StatesResponsibilities: · - Excellent employment opportunity for a Clinical Trials Manager in the Foster City area. Hybrid · - Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all company therapeutic areas. · - Clinical Operation ...
-
Clinical Trial Manager
1 week ago
Leadstack Inc Foster City, United States**Job Details**: · LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, ...
-
Technical Writer
3 weeks ago
Autonomous Vehicle Company Foster City, United States**Technical Writer - remote** · **Responsibilities** · - Collaborate with engineering, product management, and other stakeholders to gather information and understand technical concepts. · - Create and maintain technical documentation, including user manuals, API documentation, r ...
-
Associate Director, Hcp Prep Market Expansion
2 weeks ago
Gilead Sciences Foster City, United StatesFor Current Gilead Employees and Contractors: · Please log onto your · Internal Career Site · 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 dev ...
-
Technical Writer
3 weeks ago
Ryzen Solutions Foster City, United States**Responsibilities** · - Collaborate with engineering, product management, and other stakeholders to gather information and understand technical concepts. · - Create and maintain technical documentation, including user manuals, API documentation, release notes, troubleshooting gu ...
-
Parts Release Associate
2 weeks ago
Medical Device Companies Foster City, United States**Job Title: Parts Release Associate - CATIA Expertise** · **Team: Hardware Test Engineering** · The Hardware Test Engineering team is responsible for developing test platforms for validating end-to-end functionality and characterizing the performance of sub-systems, including ha ...
-
Vendor Outsourcing Associate
2 weeks ago
Leadstack Inc Foster City, United StatesLeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to par ...
-
Clinical Contract Manager
3 weeks ago
MF Associates Foster City, United StatesResponsibilities: · - Excellent employment opportunity for a Mgr, Clinical Contracts & Finance Can be based in either Foster City, CA or NJ locations. · - This is an onsite position 5 days a week. · - Currently seeking an industry leader for Sr. Manager, R&D Outsourcing within ou ...
-
Resident Area Manager
1 week ago
ISS Foster City, United StatesThe **Resident Area Manager** is responsible for ensuring all functions, initiatives, and priorities support the customer's overall business strategy. This position is responsible for the effective and efficient functioning of the operation(s) within the guidelines established by ...
-
Employee Relations Manager
2 weeks ago
MidPen Housing Corporation Foster City, United States**WHY MIDPEN** · At MidPen, we build communities that change lives. Since 1970, we have been committed to our mission: to provide safe, affordable housing of high quality to those in need; establish stability and opportunity in the lives of residents; and foster diverse communiti ...
-
Clinical Contracts Manager
3 weeks ago
TekwissenGroup Foster City, United StatesThe core responsibilities and skills required for this position include but is not limited to: · **Delivery Excellence** · - Develops global clinical development vendor strategy for a program or therapeutic area with a focus on Cell Therapy · - Manages contract and sourcing activ ...
Quality Systems Specialist III, Quality Metrics and Management Review - Foster City, United States - Gilead Sciences, Inc.
Description
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site $) 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.
We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
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. Join Gilead and help create possible, together.
Job Description
Quality Systems Specialist III , Metrics and Management Review
Job Responsibilities
Preferred Qualifications
Basic Qualifications
The salary range for this position is: $115, $149, 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:
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.
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.
