Sr Director, Quality

At 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 role will be accountable for QA operations in Turkey, Israel, UK, Switzerland, Asia 4 (Hong Kong, South Korea, Singapore, Taiwan) & Australia Affiliates, and supporting RA colleagues (who perform the local QA activities) in Europe Affiliates, as well as overseeing external distribution partners in Europe, Russia & Middle East to ensure GMP & GDP compliance for Gilead products. This role will be directly responsible for developing QA strategies that strengthen & harmonise GDP compliance across QA International regions.

The Senior Director QA 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.

The primary responsibilities include, but not limited to, the following:

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

Drive the Corporate Quality Support Model (CQSM) programme, implemented to support RA colleagues when performing local in-country QA role, and together with Regional RA Leaders, implement & lead a governance process for the CQSM.

Act as senior liaison with Gilead’s distribution partners (in QA International 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 QA International region 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 & regional RA to develop strategies supporting Gilead’s in-country QA operations, including introduction of standards, processes & procedures supporting these strategies.

Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance.

Collaborate cross-functionally and geographically with key stakeholders to establish strong working relationships with quality groups, colleagues in Regulatory Affairs, 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.

Champion the responsible use of artificial intelligence and digital tools to identify, develop, and implement efficiencies across QA International activities, while ensuring appropriate governance, data integrity, regulatory compliance, and human oversight.

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.

Education & Experience

Significant, relevant experience and a bachelor’s degree in science or related fields, MD, PharmD, PhD or an advanced business degree such as an MBA. Alternatively, broad 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.

Knowledge, Skills & Competencies

Demonstrates in-depth understanding and application of GDP principles, concepts, and standards in markets covered by QA International region, 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

Demonstrates knowledge of artificial