Description
Responsibilities
* Lead and execute internal GxP audits in alignment with the annual and quarterly audit program.
* Manage and oversee routine and complex audit activities across multiple projects, ensuring timely completion.
* Define and communicate audit plans for contract auditors; train and oversee their activities to ensure alignment with company procedures.
* Evaluate SOPs, systems, and documentation for audit readiness, regulatory compliance, and fitness for purpose.
* Develop and manage CAPAs and deviations in collaboration with cross-functional teams.
* Support Veeva QMS record development and oversight of commitments and action plans.
* Lead inspection readiness activities, including training, playbook development, and SME preparation.
* Support or lead regulatory inspections, including coordination of responses and post-inspection follow-up.
* Analyze inspection trends and integrate lessons learned into readiness planning and quality improvement.
* Maintain inspection tracking, archiving, and metrics for quality management review.
* Serve as the compliance lead and point-of-contact for assigned Kite R&D functions, programs, and / or vendors.
* Act as a Subject Matter Expert performing global risk assessments across assigned functions and programs.
* Advise study teams and R&D functions on GxP regulatory requirements, quality standards, and risk mitigation strategies.
* Deliver GxP and inspection-specific training, including standard modules and special topics.
* Ensure appropriate content and delivery of training materials; promote a culture of quality across the organization.
* Lead intra- and interdepartmental teams focused on operational improvements and regulatory change preparedness.
* Initiate and communicate operational changes in a positive and effective manner.
* Manage audit and compliance metrics to facilitate cross-functional process improvements.
* Establish and implement new tools and systems to support high standards in compliance.
* Coordinate and review the work of others; provide matrixed leadership to project teams.
* Plan and prioritize work effectively to meet tight timelines and evolving business needs.
Leadership
* Provides collaborative matrixed leadership to project and inspection teams.
* Could manage direct reports. Where, applicable hires, develops and retains diverse top talent on the team. Sets clear and elevating goals for the team and individuals direct reports. Coaches direct reports on their performance, development and career interests.
* Contributes to resourcing planning and budget, ensuring delivery against objectives and with good business judgement and priorities.
* Ensures own work, complies with established practices, policies and processes, and any regulatory or other requirements.
* Fosters a commitment to quality in individuals and a culture of quality across R&D.
Preferred Requirements
BA / BS or advanced degree in life sciences or related field
Significant experience in biopharma quality, compliance, audits, inspections, and CAPA management
Preferred: GCP, GCLP, and GPV auditing and inspection experience
Knowledge & Other Requirements
Deep understanding of QMS operations and GxP standards (GCP, GLP / GCLP, GPV, ESC)
Strong knowledge of the drug development lifecycle from early research to post-marketing
Strategic and analytical skills with ability to assess complex systems and data
Proven ability to lead without authority and influence cross-functional initiatives
Strong interpersonal, communication, negotiation, and conflict resolution skills
Ability to travel 40-50%
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 apply via the Internal Career Opportunities portal in Workday.
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