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Director, Quality Assurance
2 weeks ago
Job DescriptionAt Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.Job Description 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.Key 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 practiceResponsible for maintaining the California Board of Pharmacy (CA BoP) Wholesale Drug Permit (license) by ensuring all licensee requirements are metWork with trade operations colleagues to establish and maintain an engagement program for quality with Gilead’s US trading partners/customersPerform vendor site owner responsibilities in relevant Gilead system relating to Gilead’s US trading partners/customersResponsible 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 requirementsAct 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 practiceLead/Support market actions, including recall, of Gilead products distributed in US marketSupport 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 distributionHost NAPB or CA BoP audits of Gilead and interacts closely with external regulators/stakeholders as well as supporting external FDA audits and internal audit programsParticipate 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 marketConduct/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.Knowledge, Experience & Behaviors: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 principlesDemonstrates 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.Gilead Core Values:Integrity (always doing the right thing)Teamwork (collaborating in good faith)Excellence (working at a high level of commitment and capability)Accountability (taking personal responsibility)Inclusion (encouraging diversity)The salary range for this position is: $210,375.00 - $272,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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*.
