Senior Director, Quality Assurance - Distribution

* Serve as a key member of the GPD&A Leadership Team, who are collectively responsible for implementation of cohesive & effective QA processes across the Gilead distribution network as well as developing medium- and long-term strategic plans for all regions, which supports the overall strategic plans for the quality organization.* Coach and mentor direct reports to drive independence, development, and performance & provide leadership to ensure a safe, respectful, and inclusive work environment.* Manage financial budget, resource and workload balance with team to ensure local QA activities are performed to meet timelines and quality & compliance expectations in an equitable manner as well as ensuring that key performance indicators are monitored and reported, and key project timelines & milestones are tracked. Provides guidance on prioritization when necessary.* Act as Senior QA advisor to in-country & cluster (group of countries) QA leads with interpreting the local & regional regulatory requirements as they pertain to the distribution of Gilead products* Act as senior liaison with Gilead’s distribution partners (in US, Canada & LATAM markets) related to escalations & critical/major issues, as well as with changes that impact Gilead’s business models with these partners* Interfaces with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorate bodies.* Provide leadership for local market activities across US, Canada & LATAM regions supporting product recall and support periodic product recall challenges to ensure Gilead’s in-country distribution operations are in a state of continuous readiness in the event of needing to support product recall or other types of market action.* Lead highly complex investigations, including development and implementation of corrective and preventative action (CAPA), as required.* Partner with QA colleagues to develop strategies supporting Gilead’s in-country QA operations, including introduction of standards, processes & procedures supporting these strategies.* Partner with QA colleagues to develop strategies supporting Gilead’s in-country QA operations, including introduction of standards, processes & procedures supporting these strategies.* Collaborate cross-functionally and geographically with key stakeholders to establish strong working relationships with quality groups, colleagues in Regulatory Affairs, Global Trade Ops, Global Commercial Operations & Legal functions as well as other Gilead global functions and external distribution partners.* Act as an internal escalation contact supporting complex and high impact quality issues, concerns, and decisions.* Prime QA representative on cross-functional regional/global projects & process improvement initiatives of considerable impact to the business.* Act as deputy for the Executive Director, as required**,** supporting complex and high impact quality-related issues, escalations & other topics.* 14+years of relevant experience and a bachelor’s degree in science or related fields, or 12+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA. Alternatively, 20+years relevant experience in pharmaceutical warehouse & distribution required.* Comprehensive knowledge and experience in quality assurance in highly regulated distribution environments.* Prior people management experience required.* Broad experience across areas like customer service, warehouse operations, logistics & transport required and understanding of Oral Solid Dosage, Parenteral and Aseptic operations is beneficial.* Demonstrates in-depth understanding and application of GDP principles, concepts, and standards in US, Canada & LATAM as well as having an appreciation of them in other regions across the globe.* Capable of developing complex concepts, techniques, and standards and new applications based on quality principles and theories.* Anticipates shifts in industry trends and regulatory environment that will impact Gilead’s business needs and positions the function to respond accordingly* Demonstrates strong knowledge of aseptic processing, solid dose and general pharmaceutical manufacturing.* Capable of developing solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness, and where precedent may not exist.* Demonstrates extensive knowledge of industry best practices and trends.* Demonstrates excellent verbal, written, and interpersonal communication skills, as well as excellent influencing skills.* Is comfortable interacting with regulatory agencies as needed and possesses the ability to represent Gilead in public forums.* Demonstrates the ability to identify, understand and exceed customer expectations.* Demonstrates experience and ability to manage staff.* Demonstrates the ability to initiate and support change and respond to change requirements by continually striving to improve process or business areas, consistent with organizational strategy. #J-18808-Ljbffr