Sr. Manager, Quality Support, Data Science and Biometrics

Location
Foster City
Salary
See job description.
Posted
October 28 2020
Ref
R0015920
Discipline
Other, Other
Position Type
Full Time
Organization Type
Pharma
Job Type
Manager


Sr. Manager, Quality Support, Data Science and Biometrics
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. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. As part of our rapidly growing science-driven organization, colleagues at Gilead are revolutionizing healthcare by bringing urgently needed medicines to patients in the areas of virology, including HIV/AIDS, hematology and oncology, inflammation and respiratory diseases. We are proud to have some of the most talented colleagues from across the research, healthcare, pharmaceutical, biotechnology & business sectors, working together and supporting each other to help make a real difference to the lives of patients.

Sr. Manager, Quality Support, Data Science and Biometrics

This role will be responsible for supporting quality processes, internal audits, Regulatory Authority inspections, and associated responses and CAPAs for functional areas within Data Science and Biometrics. This role will also contribute to quality management policies and procedures and provide reportable metrics and/or KPIs to monitor quality processes.

Job Responsibilities:
  • Organizes quality control support for Data Science and Biometrics including identification of process gaps, definition and implementation of metrics, and quality monitoring.
  • Establishes and maintains standard processes for quality reviews to assess adherence to standards, conduct root cause analysis, and report on results/findings.
  • Works with stakeholders to develop and report on meaningful success metrics.
  • Recommends additional process documentation and training based on quality review findings.
  • Assists in readiness for Company process audits and Regulatory Authority inspections. Assists in the coordination of responses to Company process findings and Regulatory Authority findings.
  • Leads intra- or interdepartmental teams of an operational nature such as preparing the Company for minor changes in regulations and continuous improvement initiatives.
  • Develops and presents training using standard modules and training on special topics.
  • Initiates operational change where required and communicates change in a positive manner.
  • Considers a number of factors in planning, anticipating work and prioritizing work to meet tight timelines.
  • Defines systems or processes to consistently ensure the high standards required in the organization.
  • Fosters a commitment to quality in individuals and a culture of quality within the organization.
  • Work is performed under limited supervision. Minimal instruction is required only occasionally. Establishes and implements new tools as necessary.
  • Coordinates and reviews the work of others.
  • Manages and/or leads others in both routine and complex activities involving multiple projects and is responsible for ensuring activities are completed.
  • Coordinates quality project communications and ensures that all project customers are fully informed and knowledgeable of project activities, timelines and status.
  • Represents Data Science and Biometrics in cross-functional quality and compliance projects and activities.


Knowledge and Skills
  • Effectively delivers messages to all audiences.
  • Considers needs and level of audience in communication.
  • Uses logical persuasion in discussions and presentations.
  • Determines efficient and appropriate method of communication.
  • Understands impact of decisions and actions on business and consults with appropriate colleagues and management as applicable
  • Promotes and maintains productive working relationships.
  • Mentors others in establishing good working relationships.
  • Must have an in-depth knowledge of regulatory requirements for assigned territories.
  • Is recognized as a knowledgeable resource within the department and from other departments on a range of topics and someone whose opinion is sought as a regulatory resource.
  • Understands current global and regional trends in regulatory compliance.


Education and Experience
  • 8+ years of relevant experience and a Bachelor's degree in a relevant discipline.
  • 6+ years of relevant experience and a Master's degree, or equivalent, in a relevant discipline.
  • Relevant work experience consists of working in a pharmaceutical quality control, quality assurance or compliance environment.

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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the EEO is the Law' 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.


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Sr-Manager--Quality-Support--Data-Science-and-Biometrics_R0015920-2





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