Manager, Quality Assurance - Distribution at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Act as Designated Representative (DR) for Asegua Therapeutics LLC, ensuring compliance with NABP VAWD requirements and relevant regulations for current best practices
Maintain the Californian Board of Pharmacy Wholesale Drug Permit by meeting all licensee requirements
Serve as Deputy Designated Representative (dDR) for Gilead Sciences Inc., supporting compliance with state pharmacy and federal laws/regulations

Responsibilities

Manage medical samples process for Gilead products in the US market, ensuring compliance with the Prescription Drug Marketing Act (PDMA)
Support the engagement program for quality with Gilead’s US trading partners/customers
Support operational activities relating to implementation of the Drug Supply Chain Security Act (DSCSA) requirements
Support market actions, including recalls, of Gilead/Asegua products distributed in the US market
Support Complaints process for US market and investigations into suspect product
Generate, review, and/or approve QMS records such as deviations (internal & external), CAPAs, and Change Controls related to QA Operations supporting US market
Support implementation of existing and new US requirements & guidelines pertaining to product distribution in Gilead’s processes & procedures
Collaborate with Global QA teams and cross-functionally with Trade Operations personnel and other relevant colleagues supporting all aspects of US product distribution
Host/Support NABP audits of Asegua, as well as supporting external FDA audits and internal audit programs
Generate & maintain Standard Operating Procedures (SOPs) and other types of documentation to ensure quality objectives are met
Deliver training to colleagues in processes & procedures relevant to GDP compliance as it relates to activities covering US market
Participate in gap analyses and risk assessments of processes & procedures against relevant GDP guidelines

Skills

Key technologies and capabilities for this role

Quality AssuranceGood Distribution PracticeGDP ComplianceNABPVeriTekPharmaceutical DistributionRegulatory Compliance

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require working from an office?

This information is not specified in the job description.

What are the key responsibilities or skills required for this role?

Key responsibilities include acting as Designated Representative (DR) for Asegua Therapeutics, ensuring compliance with NABP VAWD requirements and regulations, maintaining the Californian Board of Pharmacy Wholesale Drug Permit, managing medical samples process per PDMA, and supporting DSCSA implementation, recalls, and complaints.

What is the company culture like at Gilead?

Gilead emphasizes collaboration, determination, and a relentless drive to make a difference, with people leaders driving an inclusive culture where employees feel developed and empowered. Every team member plays a critical role in scientific innovations.

What makes a strong candidate for this Manager, Quality Assurance role?

Strong candidates will have expertise in pharmaceutical distribution compliance, including NABP VAWD, GDP, PDMA, DSCSA, and state pharmacy regulations, with experience acting as a Designated Representative and managing licenses, recalls, and complaints processes.

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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