Gilead Sciences, Inc.
Senior Director, Quality
Gilead Sciences, Inc., Foster City, California, United States, 94420
Senior Director, Quality Assurance - Distribution
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.
Responsibilities
Serve as a key member of the GPD&A Leadership Team, responsible for implementation of cohesive & effective QA processes across the Gilead distribution network and developing medium‑ and long‑term strategic plans for all regions.
Coach and mentor direct reports to drive independence, development, and performance and 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, and key performance indicators are monitored and reported, with key project timelines & milestones tracked.
Act as Senior QA advisor to in‑country & cluster QA leads, interpreting 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, and changes that impact Gilead’s business models with these partners.
Interface with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorate bodies.
Provide leadership for local market activities supporting product recall and support periodic product recall challenges to ensure Gilead’s in‑country distribution operations are in a state of continuous readiness.
Lead highly complex investigations, including development and implementation of corrective and preventative action (CAPA).
Partner with QA colleagues to develop strategies, introduce standards, processes & procedures supporting Gilead’s in‑country QA operations.
Collaborate cross‑functionally and geographically with key stakeholders to establish strong working relationships with quality groups and other functions.
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 when required, supporting complex and high‑impact quality‑related issues and escalations.
Education & Experience
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 (MS, MD, PharmD, PhD) or an advanced business degree (MBA). Alternatively, 20+ years relevant experience in pharmaceutical warehouse & distribution is required.
Comprehensive knowledge and experience in quality assurance in highly regulated distribution environments.
Prior people management experience.
Broad experience across areas such as customer service, warehouse operations, logistics & transport, with an understanding of Oral Solid Dosage, Parenteral and Aseptic operations.
Knowledge, Skills & Competencies
In‑depth understanding and application of GDP principles, concepts, and standards in US, Canada & LATAM and appreciation of them in other regions.
Capability to develop complex concepts, techniques, standards and new applications based on quality principles and theories.
Anticipation of shifts in industry trends and regulatory environment that will impact Gilead’s business needs.
Strong knowledge of aseptic processing, solid dose and general pharmaceutical manufacturing.
Capable of developing solutions to complex problems requiring high ingenuity, creativity, and innovation.
Extensive knowledge of industry best practices and trends.
Excellent verbal, written, and interpersonal communication skills, and excellent influencing skills.
Comfortable interacting with regulatory agencies and ability to represent Gilead in public forums.
Ability to identify, understand and exceed customer expectations.
Experience and ability to manage staff and initiate and support change, responding to change requirements by continually striving to improve processes or business areas.
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: $243,100.00 - $314,600.00. 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*.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Equal Employment Opportunity Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status or other prohibited grounds as required by applicable federal, state and local laws. Reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990 may be requested by contacting ApplicantAccommodations@gilead.com.
Gilead Sciences will not disclose or discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to compensation information as part of their essential job functions cannot disclose pay except as permitted by law.
Job Requisition ID R0047813 Full Time/Part Time Full-Time
Job Level Director
Click below to return to the Gilead Careers site
Click below to see a list of upcoming events
Click below to return to the Kite, a Gilead company Careers site
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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.
Responsibilities
Serve as a key member of the GPD&A Leadership Team, responsible for implementation of cohesive & effective QA processes across the Gilead distribution network and developing medium‑ and long‑term strategic plans for all regions.
Coach and mentor direct reports to drive independence, development, and performance and 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, and key performance indicators are monitored and reported, with key project timelines & milestones tracked.
Act as Senior QA advisor to in‑country & cluster QA leads, interpreting 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, and changes that impact Gilead’s business models with these partners.
Interface with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorate bodies.
Provide leadership for local market activities supporting product recall and support periodic product recall challenges to ensure Gilead’s in‑country distribution operations are in a state of continuous readiness.
Lead highly complex investigations, including development and implementation of corrective and preventative action (CAPA).
Partner with QA colleagues to develop strategies, introduce standards, processes & procedures supporting Gilead’s in‑country QA operations.
Collaborate cross‑functionally and geographically with key stakeholders to establish strong working relationships with quality groups and other functions.
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 when required, supporting complex and high‑impact quality‑related issues and escalations.
Education & Experience
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 (MS, MD, PharmD, PhD) or an advanced business degree (MBA). Alternatively, 20+ years relevant experience in pharmaceutical warehouse & distribution is required.
Comprehensive knowledge and experience in quality assurance in highly regulated distribution environments.
Prior people management experience.
Broad experience across areas such as customer service, warehouse operations, logistics & transport, with an understanding of Oral Solid Dosage, Parenteral and Aseptic operations.
Knowledge, Skills & Competencies
In‑depth understanding and application of GDP principles, concepts, and standards in US, Canada & LATAM and appreciation of them in other regions.
Capability to develop complex concepts, techniques, standards and new applications based on quality principles and theories.
Anticipation of shifts in industry trends and regulatory environment that will impact Gilead’s business needs.
Strong knowledge of aseptic processing, solid dose and general pharmaceutical manufacturing.
Capable of developing solutions to complex problems requiring high ingenuity, creativity, and innovation.
Extensive knowledge of industry best practices and trends.
Excellent verbal, written, and interpersonal communication skills, and excellent influencing skills.
Comfortable interacting with regulatory agencies and ability to represent Gilead in public forums.
Ability to identify, understand and exceed customer expectations.
Experience and ability to manage staff and initiate and support change, responding to change requirements by continually striving to improve processes or business areas.
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: $243,100.00 - $314,600.00. 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*.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Equal Employment Opportunity Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status or other prohibited grounds as required by applicable federal, state and local laws. Reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990 may be requested by contacting ApplicantAccommodations@gilead.com.
Gilead Sciences will not disclose or discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to compensation information as part of their essential job functions cannot disclose pay except as permitted by law.
Job Requisition ID R0047813 Full Time/Part Time Full-Time
Job Level Director
Click below to return to the Gilead Careers site
Click below to see a list of upcoming events
Click below to return to the Kite, a Gilead company Careers site
#J-18808-Ljbffr