Sr. Director, Quality Risk Management

For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job.
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.
We empower our leaders to step up, share ideas, listen, learn, and lead.
We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged.
We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
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.
Join Gilead and help create possible, together.
Job Description Working in QA at Gilead: Quality Assurance delivers on Gilead’s commitment to bring life-changing therapies to patients through the robust QA processes and systems.
Our approach is agile, innovative, and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies.
As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development.
Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.
By joining QA within PDM, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Key Responsibilities: The Sr.
Director, Quality Risk Management (QRM) will report to the Executive Director, Quality Policies & Systems within the Global Quality Systems & Compliance organization in PDM.
This role will be primarily responsible for the development and implementation of an effective QRM program in the PDM organization and its business partners.
The incumbent will immediately supervise two additional staff members and will be responsible to grow the team structure as the program progresses.
He/She will also be responsible to lead cross-functional strategies with the community of Subject Matter Experts known as QRM Ambassadors, across PDM.
The role is highly visible and requires an influential thought leader capable of providing advice to executive leadership across Gilead in support of QRM strategies.
This role involves proactively managing risks by ensuring that risks are identified and communicated in a timely manner.
Strong leadership and collaboration skills and an enterprise mindset are essential to this role.
Develop and implement quality risk management strategies, policies, and procedures.
Design and implement a global governance process for the identification of quality risks across the organization.
Define QRM strategies and roadmap to proactively address regulatory challenges and business needs in collaboration with cross-functional PDM teams as well as its GxP partners across Gilead and Kite.
Build successful relationships with line of business risk teams to understand impact of quality risks on critical business processes and effectively communicate, evaluate, and mitigate risks.
Develop and implement a sustainable process for collecting, evaluating, and adopting regulations and guidance regarding QRM, based on data, scientific knowledge, and industry intelligence.
Provide guidance and support on risk management matters to business units across PDM and its GxP partners in R&D, IT and Kite Quality.
Conduct risk assessments and develop risk profiles for PDM and all of its products.
Develop and maintain relationships with key stakeholders, across Gilead including regulators, auditors, and other external parties.
Establish improvement requirements for electronic systems (i.
e.
Veeva Vault) to provide standardized QRM processes to cross-functional partners.
Leverage data science to improve existing QRM tools and capabilities, develop co-relations between quality events to proactively identify risks.
Coach and mentor junior staff supporting QRM program deliverables.
Other responsibilities as required.
Knowledge, Experience & Skills: At least 14 years of relevant work experience in the Biotechnology field with a BS/BA or 12+ Years with MS/MA or MBA.
At least 5 years of people leader experience.
Direct experience building effective QRM programs in the Biopharmaceutical environment.
Demonstrates thorough knowledge of compliance requirements and understanding of current global and regional trends in risk management and compliance in Biopharmaceuticals.
Thorough Knowledge of ICH Q9 and ISO 14971 and other applicable regulatory frameworks.
Expert Working knowledge experience with risk management tools (e.
g.
, FMEA, risk ranking and filtering) Able to maintain a balance between being strategic/big-picture thinker and taking deeper tactical dives as needed.
Excellent interpersonal skills including ability to effectively speak with courage and candor across organizational levels and functions.
Strong relationship management skills including ability to adapt communication style and content to suit audience and stakeholder needs.
Experience in developing and generating quality system metrics/trending.
The salary range for this position is: $237,660.
00 - $307,560.
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.
For jobs in the United States: As an equal opportunity employer, Gilead Sciences Inc.
is committed to a diverse workforce.
Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 PAY TRANSPARENCY NONDISCRIMINATION PROVISION 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.
For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job.