Quality Assurance Specialist
OkloSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalsIndustries
Requirements
- Act as Designated Representative (DR) for Gilead Sciences Inc., ensuring compliance with NABP VAWD requirements and relevant regulations for Good Distribution Practice (GDP)
- Maintain California Board of Pharmacy (CA BoP) Wholesale Drug Permit by meeting all licensee requirements
- Serve as QA SME for DSCSA compliance and provide strategic support for operational processes
- Act as Deputy Designated Representative (dDR) for Asegua, supporting compliance with state and federal laws
- Coach, mentor direct reports, manage workload prioritization, monitor KPIs, and track project timelines
- Perform vendor site owner responsibilities in Gilead systems for US trading partners/customers
- Provide guidance on interpretation and application of US product distribution requirements
- Act as PDMA Quality representative in Gilead’s Sample Compliance Committee (SCC)
- Host NABP or CA BoP audits and interact closely with auditors
Responsibilities
- Work with trade operations to establish and maintain a quality engagement program with US trading partners/customers
- Lead/support market actions, including recalls, for Gilead products in the US market
- Support shipping & distribution-related complaints process and investigations into suspect products
- Manage QMS records such as deviations (internal & external), CAPAs, and Change Controls for US market distribution QA operations
- Collaborate with Global QA teams, Trade Operations, Global Supply Chain, and other colleagues on US product distribution
- Ensure local QA activities meet timelines, quality, and compliance expectations
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the employment type for this Director, Quality position?
This is a full-time position.
Is this Director, Quality role remote or office-based?
This information is not specified in the job description.
What are the key responsibilities for the Director, Quality role?
Key responsibilities include acting as Designated Representative (DR) for compliance with NABP VAWD and regulations, maintaining the California Board of Pharmacy Wholesale Drug Permit, coaching direct reports, performing vendor site owner responsibilities, and providing guidance on US product distribution requirements including DSCSA compliance.
What is the company culture like at Gilead Sciences?
Gilead emphasizes collaboration, determination, and a relentless drive to make a difference, with people leaders playing a key role in evolving the culture to ensure every employee feels included, developed, and empowered.
What makes a strong candidate for the Director, Quality position?
Strong candidates will have expertise in quality assurance for product distribution, experience acting as a Designated Representative for compliance with NABP VAWD and California Board of Pharmacy requirements, and skills in coaching teams, vendor management, and providing strategic guidance on regulations like DSCSA.
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
Benefits
Paid family time off and paid parental time off
Generous 401(k) contribution matching
Comprehensive medical plans that cover both physical and mental healthcare
Global Wellbeing Reimbursement
Time Off
Global Volunteer Day
Giving Together Program
Employee Support Programs
Flexible Work Options
Risks
Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.
Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.
Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.
Differentiation
Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.
Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.
Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.
Upsides
Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.
Investment in digital health technologies enhances Gilead's R&D and patient engagement.
Focus on sustainability improves Gilead's operational efficiency and corporate reputation.
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