Manager, Quality Assurance - Distribution

Role Summary

The QA Manager (US market) supports distribution of Gilead products (including prescription samples) within the US market. This role acts as Designated Representative (DR) for Asegua Therapeutics LLC’s (Asegua), and works closely with their manager as well as the Director QA (US) and with internal and external stakeholders to ensure quality requirements are met and compliance to Good Distribution Practice (GDP) is adhered to for Gilead products throughout the US distribution network to patients.

Responsibilities

• Act as Designated Representative (DR), for Asegua, responsible for ensuring compliance with NABP Verified-Accredited Wholesale Distributors (VAWD) requirements as well as all relevant regulations pertaining to current best practice
• Maintain the Californian Board of Pharmacy Wholesale Drug Permit by ensuring all licensee requirements are met
• Manage medical samples process for Gilead products in the US market and ensure compliance with the PDMA
• Support the engagement program for quality with Gilead’s US trading partners/customers
• Support operational activities relating to implementation of the DSCSA requirements, as required
• Act as Deputy Designated Representative (dDR) for Gilead Sciences Inc., supporting the DR to ensure compliance with state pharmacy state and federal laws and regulations pertaining to current best practice
• Support market actions, including recall, of Gilead/Asegua products distributed in US market
• Support Complaints process for US market and investigations into suspect product, as required.
• Generate, review and/or approve QMS records such as deviations, CAPAs & 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 work cross-functionally with Trade Operations personnel and other relevant colleagues supporting all aspects of US product distribution
• Host/Support NAPB audits of Asegua as well as supporting external FDA audits and internal audit programs, as required
• Generate & maintain SOPs and other 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 and corporate standards
• Participate in local and corporate projects and process improvement initiatives, as required

Qualifications

• 6+ years of relevant experience in the pharmaceutical industry and a BS or BA (pharmacy degree or equivalent advantageous) or 4+ years of relevant experience and a MS or MA
• Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment
• Experience in US market to include supporting FDA inspections
• Proficiency in GDP, DSCSA, and PDMA requirements
• Ability to assess and communicate the impact of requirements to the business and engage with multiple stakeholders to achieve shared objectives
• Excellent organization and prioritization skills with ability to meet tight timelines
• Attention to detail and consistently high compliance standards
• Excellent verbal, written, and interpersonal communication skills