Sr Associate Scientist, Analytical Ops
Sr Associate Scientist, Analytical Ops
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
Specific Responsibilities required for the Position:
- Managing a minimum of 2 direct reports and focuses on the support and management of the Compliance & Training group quality records management programs.
- Management of the Change Management (CM) and CAPA support programs.
- Manage staff supporting CM record activities to ensure on-time closure.
- Support and/or manage CM record support staff to ensure appropriate impact assessments and justification are completed.
- Ensure and/or lead the training of staff to support timeline management and technical writing in support of CM quality records including Change Control for document revisions
- Support or manage staff supporting CAPA record activities to ensure on-time closure.
- Support and/or manage CAPA record support staff to ensure appropriate and relevant CAPA plans are developed, implemented, and timeline maintained.
- Ensure and/or lead the training of staff to support timeline management and technical writing in support of CAPA records
- Lead & coordinate cross functional projects with limited direction
- Perform metrics as appropriate for CMs, LEs, deviations, CAPAs, ECs, and EETs
- Perform monthly, quarterly and annual reports of quality records and assess trends
- Support the Compliance & Training manager providing necessary backup for manager absences
Required Education, Skills & Experience:
- M.S degree with 5+ years of experience, OR B.S degree with 7+ years of experience
- Strong verbal communication skills and interpersonal skills
- Must think critically and creatively while able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills
- Demonstrated ability to collaborate as part of a team to develop new, or improve upon existing, business processes or procedure
- Previous Management experience
- Experience working as a manager in a GMP supporting role
- Experience based knowledge to act as a quality systems resource for other employees within the department
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 firstname.lastname@example.org 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-Associate-Scientist--Analytical-Ops_R0020134-1
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