Gilead Sciences Looking for Senior Manager, Clinical Quality Business Partners, Therapeutic Area Support at Remote Full Time

Job details

Job type full-time

Full job description

Gilead sciences is continuing to hire for all open rolesOur interview process may be conducted virtually and some roles will be asked to temporarily work from homeOver the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

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Job description

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 an experienced srManager to join our clinical quality business partner team who is ready to dive-in to support our therapeutic areas and clinical development programsIn this role you will represent r&d quality & medical governance on the global clinical study management teams advising on areas of gcp risk.

This role is suited to candidates who possess expert good clinical practice (gcp) knowledge, strong project management and communication skills, strategic thinking ability and proven success in a matrixed organization.

As part of global r&d quality & medical governance you will be joining a supportive team that fosters constructive collaboration in support of our clinical development programs promoting a culture of quality.

**note: this role can be based in: morris plains, new jersey, seattle, wa, foster city, ca, or remote.**

Primary responsibilities:

Serve as clinical quality business partner lead for assigned clinical trial programsHandle multiple projects and ensure overall and timely completion of tasks.
Act as subject matter expert performing global risk assessment for investigator site audit planning.
Collaborate with the audit, inspection and capa management team within r&d quality & medical governance.
Works closely with clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement.
Assists in readiness preparation, and/or directly support regulatory agency inspectionAssist in coordination of response to any findings.
Support deviation identification, reporting, and capa development.
Leads intra/inter-departmental teams that support operations (e.gEvaluation of a new regulation).
Evaluate, write and/or review operating procedures (e.gSops), 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 8+ years of relevant experience (6+ years of relevant experience with an applicable ms).
At least 5 years of audit and compliance experienceMust have significant gcp audit and compliance experienceBio-pharma sponsor experience 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 suiteExperience 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 10% required.

About gilead r&d quality & medical governance:

Gilead r&d quality & medical governance is a phenomenal place to develop your skills and expertiseOur 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 professionals dedicated to helping deliver life-saving therapies for unmet needsWe 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 missionOur 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?

For colorado job applicants: the salary range for this position is:

$124,240.00 – $186,360.00

Gilead considers a range of factors, including background and experience, when determining base compensationThese considerations means actual compensation will vary.
Position is also eligible for bonus and benefitsFor more information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing

For jobs in the united states:

As an equal opportunity employer, gilead sciences incIs committed to a diverse workforceEmployment 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 lawsIn 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 [email protected] for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, gilead has made the decision to require all u.sEmployees and contractors to receive the covid-19 vaccines as a condition of employment“full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administeredAnyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

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Posted 10 days ago