Senior Manager, Clinical Quality Business Partners, Therapeutic Area Support

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 Sr. Manager to join our Clinical Quality Business Partner team who is ready to dive-in to support our therapeutic areas and clinical development programs. In 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, or Foster City, CA.**

Primary Responsibilities:

• Serve as Clinical Quality Business Partner lead for assigned clinical trial programs. Handle 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 inspection. Assist in coordination of response to any findings.
• Support deviation identification, reporting, and CAPA development.
• Leads intra/inter-departmental teams that support operations (e.g. evaluation of a new regulation).
• 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 8+ years of relevant experience (6+ years of relevant experience with an applicable MS).
• At least 5 years of audit and compliance experience. Must have significant GCP audit and compliance experience. Bio-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 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 10% required.

About Gilead R&D Quality & Medical Governance:

Gilead R&D Quality & Medical Governance 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 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?

For jobs in the United States:
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