Director, GCP Quality & Compliance
Director, GCP Quality & 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 Director who is ready to dive-in to support our clinical development programs. As a Clinical Quality and Compliance Director, you will support and work with our clinical study management teams and teammates across R&D Quality and Compliance.
We need someone with strong leadership skills, expert 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 and supportive team that fosters constructive collaboration in support of our clinical development programs.
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.
- Active member of the R&D Quality and Compliance Clinical management team
- Lead Clinical Compliance activities and compliance staff in one or more therapeutic areas. Handle multiple projects and ensure overall and timely completion of tasks.
- Works closely with compliance staff and clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement.
- Support deviation identification, reporting, and CAPA development
- Responsible for ensuring the development of audit strategy plan(s) and ensuring timely execution of plans for programs.
- Oversees GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors.
- Represent Regulatory Compliance in Working Groups as appropriate
- Supervise, develop, train and manage internal staff as appropriate.
- Ensure oversight of contracts auditors.
- Effective compliance reporting to senior management and relevant quality governance forums
- Leads intra/inter-departmental teams and/or projects that support continuous improvement of the Quality Management System. Builds positive support and acts as role model for change.
- May lead/support management of regulatory inspection activities such as readiness preparation, inspection management, and/or response management.
- Leads intra or interdepartmental teams of an operational nature such as preparing the Company for minor changes in regulations, continuous improvement initiatives.
- Fosters a commitment to quality in individuals and a culture of quality within the organization.
- BA or BS and Significant relevant experience
- Must have significant GCP audit and compliance experience. Clinical Quality Assurance/Compliance experience required. 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:
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