Senior Manager, GCP Quality & Compliance, R&D Quality and Compliance

Senior Manager, GCP Quality & Compliance, R&D Quality and Compliance
Ireland - Dublin

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


Would you like to play a crucial role in developing life-saving therapies? Are you excited to use your scientific insight to partner with internal teams, and external partners as we strive to cure unmet medical needs?

We are looking for a Clinical Quality and Compliance Sr. Manger who is ready to dive-in to support our clinical development programs. You will support and work with our clinical study management teams and teammates across R&D Quality and Compliance.

We need someone with strong Good Clinical Practice (GCP) knowledge, audit skills, communication, and facilitation skills, and the ability to manage multiple projects.

You will be a part of an expert team supporting global clinical development programs, with a special emphasis on pediatric trials, based in Gilead's new location in Dublin, Ireland.

Primary Responsibilities

• Serve as Clinical Compliance Lead for assigned clinical trial programs in one or more therapeutic areas. Handle multiple projects and ensure overall and timely completion of tasks.
  
• Leads development of audit strategy plan(s) and ensuring timely execution of plans for assigned projects/programs.
  
• Provide training and oversight of contracts auditors.
  
• Manages and/or leads GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors.
  
• Works closely with clinical study management teams to provide expert clinical compliance information, manage identified issues, escalates as appropriate, and support continuous improvement.
  
• Support deviation identification, reporting, and CAPA development
  
• Assists in readiness preparation, and/or directly support regulatory agency inspection. Assist in coordination of response to any findings.
  
• Evaluate, write and/or review operating procedures (e.g. SOPs), and perform other activities in support of an integrated cross-functional quality management system (QMS).
  
• Fosters a commitment to quality in individuals and a culture of quality within the organization.
  

Qualifications

• BA or BS and significant relevant experience
  
• Must have at significant number of years GCP audit and compliance experience. Bio-pharma sponsor or CRO experience required.
  
• Significant experience with pediatric clinical trials strongly preferred.
  
• Recognized as an expert resource on a range of clinical compliance topics.
  
• Strong verbal and written communication skills and interpersonal skills.
  
• Proficient in Microsoft Office suite. Experience with audit management/CAPA management programs strongly preferred.
  
• Excellent organization skills and project management.
  
• Able to work equally well as part of a team or independently
  
• Ability to travel approximately 25% required.
  

About Gilead R&D Quality and Compliance

Gilead R&D Quality and Compliance is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team.

We are a committed team of highly skilled Quality and Compliance professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do.

We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career.

Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world?

Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.


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/Ireland---Dublin/Senior-Manager--GCP-Quality---Compliance--R-D-Quality-and-Compliance_R0018640-1





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