Director, Quality Assurance - Distribution

Gilead Sciences • Foster City, CA

3d

About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. The Director Quality Assurance, US market, a member of the Global Product Distribution & Affiliates (GPD&A) group, is responsible for supporting distribution of Gilead products within the US market. The Director QA acts as Designated Representative (DR) for Gilead Sciences Inc. and works with internal & external stakeholders to ensure quality requirements are met and compliance to Good Distribution Practise (GDP) is adhered to for Gilead products, throughout the US distribution network to patients.

Requirements

• BS/BA degree with 12+ years or MS/MA degree with 10+ years of relevant experience in the pharmaceutical industry with a pharmacy degree or equivalent.
• Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.
• Experience in US market to include supporting/hosting FDA inspections.
• Demonstrates proficiency in Good Distribution Practices (GDP), Prescription Drug Marketing Act (PDMA), and Drug Supply Chain Security Act (DSCSA) requirements as well as risk management principles
• Demonstrates a highly developed knowledge of compliance requirements, and an understanding of current global and regional trends in compliance,
• Capable of assessing and communicating the impact of relevant requirements to the business.
• Ability to engage and manage multiple stakeholders to achieve the objective.
• Demonstrates excellent influencing and negotiation skills.
• Excellent verbal, written and interpersonal skills are required.
• Organized with systematic approach to prioritization.

Responsibilities

• Act as Designated Representative (DR), for Gilead Science Inc., responsible for ensuring compliance with National Association or Boards of Pharmacies (NABP) Verified-Accredited Wholesale Distributors (VAWD) requirements as well as all relevant regulations pertaining to current best practice
• Responsible for maintaining the California Board of Pharmacy (CA BoP) Wholesale Drug Permit (license) by ensuring all licensee requirements are met
• Work with trade operations colleagues to establish and maintain an engagement program for quality with Gilead’s US trading partners/customers
• Perform vendor site owner responsibilities in relevant Gilead system relating to Gilead’s US trading partners/customers
• Responsible for providing guidance on interpretation and application of existing and new US requirements pertaining to product distribution.
• Act as the QA SME relating to DSCSA compliance and provide strategic support for operational processes relating to implementation of DSCSA requirements
• Act as prescription Drug Marketing Act (PDMA) Quality representative in Gilead’s Sample Compliance Committee (SCC)
• Act as Deputy Designated Representative (dDR) for Asegua (a subsidiary of Gilead Sciences Inc), supporting the DR to ensure compliance with state pharmacy state and federal laws and regulations pertaining to current best practice
• Lead/Support market actions, including recall, of Gilead products distributed in US market
• Support shipping & distribution-related complaints process for US market & investigations into suspect product, as required.
• Manage QMS records such as deviations (internal & external), CAPAs & Change Controls related to QA Operations supporting US market distribution.
• Collaborate with Global QA teams as well as working cross-functionally with Trade Operations personnel, Global Supply Chain and other relevant colleagues supporting all aspects of US product distribution
• Host NAPB or CA BoP audits of Gilead and interacts closely with external regulators/stakeholders as well as supporting external FDA audits and internal audit programs
• Participate in developing/approving Standard Operating Procedures (SOPs) and other types of documentation to ensure quality objectives are met.
• Participate in the development & delivery of training programs relevant to GDP, PDMA & DSCSA compliance as they relate to activities covering US market
• Conduct/Participate in gap analyses and risk assessments of processes & procedures against relevant GDP, PDMA & DSCSA guidelines as well as corporate standards.
• Participate in, or where relevant lead, local and corporate projects, and process improvement initiatives, as required.

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees