Senior Director, Quality Assurance - Distribution

Gilead Sciences • Foster City, CA

1d

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 role will be accountable for QA operations in US, Canada & LATAM markets to ensure GMP & GDP compliance for Gilead products. This role will be directly responsible for developing QA strategies that strengthen & harmonize GDP compliance across the US, Canada & LATAM regions. The Senior Director, Quality Assurance - Distribution will sit on the GPD&A leadership team, who are responsible for the management and operational development of strategy for Gilead Quality Distribution & QA Operations within each market Gilead supply, and the individual is expected to actively participate in, and support the goals of this Leadership team. The role also requires someone with a track record of excellent people leadership & influencing skills, experience in developing & implementing strategic goals, as well as hands-on experience supporting multiple QA operating models across a global commercial network and delivering successful governance & QA operating processes.

Requirements

• 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.

Responsibilities

• 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.

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

What This Job Offers

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