Associate Director, Connect Quality

Associate Director, Connect Quality
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

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.

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 Clinical Trial Capabilities (CTC) organization offers infrastructure, support, and solutions enabling the Clinical Operations and Development Organizations with rapid, efficient, and compliant clinical trial execution to deliver transformative medicines to patients. The Connect function within the CTC organization is a centralized process department that specializes in process improvements, procedural documents, and quality and inspection readiness for Clinical Operations.

The Associate Director, will be a key member of the Connect Quality team and collaborate with Clinical Operations personnel to ensure quality, proactively identify risk, mitigate non-compliance and support inspection readiness activities. The position will partner closely with Research & Development Quality personnel.

Primary Responsibilities:
Lead efforts to increase a culture of quality within the Clinical Operations organization.Develop, deploy and maintain Inspection Readiness activities for key programs within Clinical OperationsProvide ongoing support, guidance, consultation pre, during and post inspection readiness phasesPartner with clinical study teams on risk identification/management/mitigation activities Gather, analyze and share best practices and lessons learned from audit, inspection, deviation activitiesWork with relevant stakeholders to identify areas for improvement from audits, inspections, deviations, and corresponding appropriate next stepsCompile and communicate quality related metrics, risks, and quality challenges to teams and management.Provide guidance for investigations, root cause analysis, as well as development of corrective and preventive action (CAPA) plans for deviations and/or observations of non-compliance.Maintain awareness of changes within the industry and regulatory environment to ensure Clinical Operations alignment Determine, develop, execute Effectiveness Checks for applicable CAPAsCoordination of Clinical Operations internal process audit activitiesLead activities pertaining Clinical Operation internal deviationsCreate and deploy procedure to conduct compliance checks for designated processes
Qualifications
BA or BS and 10+ years' experience in compliance in pharmaceutical/biotechnology industry.Excellent working knowledge of of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studiesDirect experience at the Sponsor level with front and back room inspection operations. Ability to build strong relationships to foster a collaborative approach to proactive compliance activities.Key stakeholders include clinical systems, TMF, RBQM, Vendor quality/oversight, thus direct experience with those areas preferredStrong verbal, written, communication, and interpersonal skills.Ability to analyze complex situations, develop multiple options/solutions within regulatory guidance.

The salary range for this position is: $191, $247, 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:

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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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 for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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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.

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