Quality Systems Specialist II GxP Training

Quality Systems Specialist II GxP Training
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. Join Gilead and help create possible, together.

Job Description

Quality Systems Specialist II - GxP Training

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing 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 Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Reporting to the Global Quality Systems and Compliance organization, the Quality Systems Specialist II - GxP Training will be responsible for partnering with Business Leaders to drive user-focused strategies to ensure effective and compliant training is delivered to the Pharmaceutical Development and Manufacturing organization of Gilead. This role is for a change leader who is ready to help modernize the learning experience and deliver learner focused training plans.

Responsibilities:
Develops training curricula based on the key elements of the Quality System.
Implements learner focused training plans in alignment with job functions and roles.
Partners with cross-functional business partners to streamline and enhance functional training matrices.
Creates efficient and effective training program with Subject Matter Experts (SMEs) across different business functions.
Partners with Business Process Owners to implement global training programs for new processes or systems.
Assesses the training impact of changes, the appropriate learning audience, and training modality.
Improves process efficiencies by representing the PDM Training organization cross-functionally and proactively elevating the training experience for personnel.
Collects and reports on key performance indicators and training metrics.
Develops, reviews, and advises on training content in compliance with policies, procedures, and applicable regulations.
Coordinates planning, organization, and implementation of projects within specified objectives and timelines.
Provides additional support and assistance on tasks and projects as directed by the manager.

Minimum Qualifications:
Masters degree and 2 + years of relevant experience; or Bachelors degree and 4+ years of relevant experience.

Preferred Qualifications:
Prior experience in pharmaceutical industry is preferred.
Demonstrates proficiency in Good Manufacturing Practices (GMPs).
Demonstrates strong understanding of roles and functions within the Pharmaceutical Development and Manufacturing organization.
Demonstrates proficiency in application of quality systems principles, concepts, industry practices, and standards.
Demonstrates functional and process knowledge to support the integrated design and development of training programs.
Demonstrates ability to effectively work with cross-functional project teams and manage multiple projects/priorities.
Demonstrates excellent verbal, technical writing, and interpersonal communication skills.
Proven organizational skills, planning skills, and ability to work effectively within teams.
Demonstrates intellectual curiosity, desire to learn, and ability to problem-solve.
Ability to affect decisions, guide and communicate effectively with stakeholders, build collaborative relationships, and understand functional processes and goals.
Ability to quickly adapt to changing circumstances; recognizes risks, escalates, and re-prioritizes accordingly.
Demonstrates proficiency in Microsoft Office applications.
Prior experience with a Learning Management System (LMS).
The ideal candidate has held various roles in a GMP environment, including Manufacturing, Quality Control, Quality Assurance, Regulatory, etc.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community:

The salary range for this position is: $99, $129, 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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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.

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