Chief of Staff - R&D
Addepar$143,000 - $224,000/year
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries
Requirements
- Reports to the SVP of Global Regulatory Affairs, Patient Safety and Quality
- Experience leading a global team in a cross-functional and multi-cultural environment
- Ability to build and manage a thriving global R&D Quality department
- Expertise in providing quality management oversight for R&D and Medical Affairs across regions
- Strong collaboration skills with stakeholders, including Gilead’s Chief Compliance Officer
- Knowledge of global regulations, GxP quality standards, industry laws, rules, regulations, and guidance documents
- Capability to represent the organization in meetings with regulatory authorities and stakeholders worldwide
Responsibilities
- Provide strategic leadership to the global R&D Quality & Medical Governance organization, including clinical compliance and pharmacovigilance, electronic systems and laboratory compliance, and quality documents and training administration
- Provide oversight to Medical Affairs quality and governance and collaborate with Gilead’s Chief Compliance Officer on healthcare compliance execution
- Promote a culture of GxP quality across R&D with the highest levels of integrity to meet all global standards
- Represent Gilead and the R&D Quality and Medical Governance organization in meetings with regulatory authorities and other stakeholders around the world
- Ensure appropriate quality measures and controls are in place to align with and support industry laws, rules, regulations, and guidance documents
- Enable efficiency and continuous improvement through the build-out of process capabilities, including a Global Process Owner network, process maps, and end-to-end visualization of R&D activities
- Ensure ongoing compliance in R&D operations and prepare for regulatory agency inspections and internal audits around the world
- Oversee the management of all R&D quality issues, including regulatory compliance with CAPAs, transaction monitoring, quality control, continuing education/tracking, and data privacy (in collaboration with the Privacy, Cybersecurity and Information Governance team)
- Lead risk assessments and implement compliance monitoring and testing program across R&D with respect to R&D quality
- Set the strategic direction for the risk management and engagement of R&D quality for third-party vendors
- Lead the approach for employee training sessions on internal GxP policies and procedures
- Collaborate with key stakeholders for R&D quality audit programs to develop audit strategy
Skills
Quality Management
R&D Quality
Regulatory Affairs
Patient Safety
Medical Affairs
Global Team Leadership
Cross-Functional Collaboration
Virology
Oncology
Inflammation
Gilead Sciences
Develops and commercializes biopharmaceuticals
About Gilead Sciences
Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.
Foster City, CaliforniaHeadquarters
1987Year Founded
$15,873.6MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees