Gilead Sciences
Sr Director, R&D Quality
Gilead Sciences
Join to apply for the
Sr Director, R&D Quality
role at
Gilead Sciences
Job Overview R&D Quality is seeking a Senior Director, Quality Operations Excellence Lead to join our R&D Program Quality Team. In this role you will lead and set a strategy for ensuring the execution of Quality Oversight activities for all products in development at Gilead. Through the establishment of standards and promotion of best practices, you will drive optimized performance for key focus areas critical to the success of R&D Quality.
Acting as trusted business partners, you and your team will work closely with R&D Program Therapeutic Area Leads to oversee the consistent performance and outputs of key activities such as study oversight plans, critical quality event management, serious breach assessments, study/program/therapeutic area analytics, and Quality Briefs. Reporting to the Executive Director, R&D Program Quality, you will also be a key member of the R&D Quality and Medical Governance Extended Leadership Team, advancing a culture of Quality across Gilead.
Job Responsibilities
Design and implement an integrated Quality Operations Strategy for the Gilead R&D portfolio.
Establish standards, tools & performance indicators for key activities including quarterly metrics & risk reporting for Program/Study Quality Briefs, Due Diligence, Quality Oversight Plans, critical quality event management, serious breach assessment and reporting.
Lead the analysis and interpretation of key quality data in Program/Study Quality Briefs for the presentation and reporting to functional and executive leadership.
Lead and oversee lessons learned activities driving continuous improvement.
Optimize R&D Program Quality performance by implementing a flexible centralized resourcing model for high-demand activities.
Oversee and lead critical quality event investigations and serious breach assessments.
Act as point of contact (PoC) for due diligence activities ensuring collaboration with Regulatory and Safety leads.
Collaborate with Oncology, Virology and Inflammation Program Leads in assessing cross‑therapeutic area risks.
Act as PoC for Program Quality for key initiatives within Global R&D Quality and RSQ.
Providing guidance and training for core quality management capabilities such as risk management, quality event management and issue escalation, and deviation and CAPA management.
Establish strong partnership with key business stakeholders, including Clinical Development, Clinical Operations, Regulatory, Safety, and Clinical Data Sciences.
Identify and drive continuous quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations.
Serve as an expert and provide guidance on and interpretation of global GCP regulations and Gilead standards for internal stakeholders.
Supports overall R&D Quality goals and objectives including but not limited to Quality strategy & goals.
Supervise, develop, train and manage internal staff as needed. This includes fostering a commitment to quality in individuals and a culture of quality within the organization.
Leads intra or interdepartmental teams such as goal and continuous improvement initiatives.
Qualifications
Bachelor’s degree with 12+ years; Master’s degree with 10+ years; or PhD with 8+ years of R&D quality assurance compliance experience.
Clinical Quality Assurance/Compliance experience in a Bio‑pharma sponsor organization required.
Proven experience in managing compliance programs required.
Experience in implementing principles for Quality Risk Management (ICH Q9, ICH E6 R3) required.
Familiarity with GVP and 21 CFR Part 11 electronic systems and compliance activities is preferred.
Experience leading business process improvement projects required.
Proven effective verbal, written, interpersonal skills to include delivering presentations to executives.
Recognized as an expert resource on a range of compliance topics.
Management of junior and senior staff.
Proficient in Microsoft Office suite.
Experience with Inspection and Audit management/CAPA management programs strongly preferred.
Excellent organizational and project management skills.
Able to lead and mentor effective cross functional teams.
Ability to travel is approximately 20% required.
About Gilead R&D Quality Gilead R&D Quality is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team. We are a committed team of highly skilled Quality professionals dedicated to helping deliver life‑saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do. We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career.
Location & Work Arrangement This is a hybrid (3 days per week) role based in Foster City.
Compensation 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*.
Benefits Information For Additional Benefits Information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing.
Equal Employment Opportunity Statement 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 non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
In order to ensure 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, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT.
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT.
Gilead Sciences will not discharge or in any other manner 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 the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
#J-18808-Ljbffr
Join to apply for the
Sr Director, R&D Quality
role at
Gilead Sciences
Job Overview R&D Quality is seeking a Senior Director, Quality Operations Excellence Lead to join our R&D Program Quality Team. In this role you will lead and set a strategy for ensuring the execution of Quality Oversight activities for all products in development at Gilead. Through the establishment of standards and promotion of best practices, you will drive optimized performance for key focus areas critical to the success of R&D Quality.
Acting as trusted business partners, you and your team will work closely with R&D Program Therapeutic Area Leads to oversee the consistent performance and outputs of key activities such as study oversight plans, critical quality event management, serious breach assessments, study/program/therapeutic area analytics, and Quality Briefs. Reporting to the Executive Director, R&D Program Quality, you will also be a key member of the R&D Quality and Medical Governance Extended Leadership Team, advancing a culture of Quality across Gilead.
Job Responsibilities
Design and implement an integrated Quality Operations Strategy for the Gilead R&D portfolio.
Establish standards, tools & performance indicators for key activities including quarterly metrics & risk reporting for Program/Study Quality Briefs, Due Diligence, Quality Oversight Plans, critical quality event management, serious breach assessment and reporting.
Lead the analysis and interpretation of key quality data in Program/Study Quality Briefs for the presentation and reporting to functional and executive leadership.
Lead and oversee lessons learned activities driving continuous improvement.
Optimize R&D Program Quality performance by implementing a flexible centralized resourcing model for high-demand activities.
Oversee and lead critical quality event investigations and serious breach assessments.
Act as point of contact (PoC) for due diligence activities ensuring collaboration with Regulatory and Safety leads.
Collaborate with Oncology, Virology and Inflammation Program Leads in assessing cross‑therapeutic area risks.
Act as PoC for Program Quality for key initiatives within Global R&D Quality and RSQ.
Providing guidance and training for core quality management capabilities such as risk management, quality event management and issue escalation, and deviation and CAPA management.
Establish strong partnership with key business stakeholders, including Clinical Development, Clinical Operations, Regulatory, Safety, and Clinical Data Sciences.
Identify and drive continuous quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations.
Serve as an expert and provide guidance on and interpretation of global GCP regulations and Gilead standards for internal stakeholders.
Supports overall R&D Quality goals and objectives including but not limited to Quality strategy & goals.
Supervise, develop, train and manage internal staff as needed. This includes fostering a commitment to quality in individuals and a culture of quality within the organization.
Leads intra or interdepartmental teams such as goal and continuous improvement initiatives.
Qualifications
Bachelor’s degree with 12+ years; Master’s degree with 10+ years; or PhD with 8+ years of R&D quality assurance compliance experience.
Clinical Quality Assurance/Compliance experience in a Bio‑pharma sponsor organization required.
Proven experience in managing compliance programs required.
Experience in implementing principles for Quality Risk Management (ICH Q9, ICH E6 R3) required.
Familiarity with GVP and 21 CFR Part 11 electronic systems and compliance activities is preferred.
Experience leading business process improvement projects required.
Proven effective verbal, written, interpersonal skills to include delivering presentations to executives.
Recognized as an expert resource on a range of compliance topics.
Management of junior and senior staff.
Proficient in Microsoft Office suite.
Experience with Inspection and Audit management/CAPA management programs strongly preferred.
Excellent organizational and project management skills.
Able to lead and mentor effective cross functional teams.
Ability to travel is approximately 20% required.
About Gilead R&D Quality Gilead R&D Quality is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team. We are a committed team of highly skilled Quality professionals dedicated to helping deliver life‑saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do. We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career.
Location & Work Arrangement This is a hybrid (3 days per week) role based in Foster City.
Compensation 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*.
Benefits Information For Additional Benefits Information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing.
Equal Employment Opportunity Statement 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 non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
In order to ensure 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, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT.
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT.
Gilead Sciences will not discharge or in any other manner 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 the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
#J-18808-Ljbffr