QA Specialist II

Gilead Sciences, Inc.; Foster City (CA); On-site; USD 102,000 - 133,000; Full time

Job summary

Gilead Sciences, Inc. seeks a skilled professional to lead complaint investigations and ensure regulatory compliance, contributing significantly to quality management and product safety. Candidates should have substantial experience in GMP environments and the ability to communicate effectively with regulatory authorities. This role offers the opportunity to impact patient safety and product quality directly.

Qualifications

• Bachelor’s degree and 4+ years of relevant experience in a GMP environment or Master’s degree with 2+ years.
• Preferred experience in the pharmaceutical industry.
• Proficiency in QA systems principles and FDA/EMEA standards.

Responsibilities

• Responsible for complaint investigations and ensuring compliance with regulatory standards.
• Leads complex investigations and implements corrective actions.
• Collaborates with internal and external stakeholders to ensure alignment on processes.

Skills

Proficiency in Good Manufacturing Practices (GMPs)

Technical writing skills

Verbal communication skills

Education

Bachelor’s degree in relevant field

Master’s degree in relevant field

Tools

Microsoft Office applications

Job description

Job Description

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

Specific Job Responsibilities

Responsible for clinical and commercial complaint investigations.

Responsible for tracking and trending of complaints across all Gilead Sciences sites and presents data periodically for Quality Management Review

Leads and co-ordinates complex complaint investigations, including development and implementation of corrective actions.

Interfaces with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorates. Prepares and presents Complaint data to the regulatory agency inspections.

Writes and/or implements changes to controlled documents (e.g., SOPs, investigational protocols etc.) as needed.

Supports Annual Product Quality Reviews, CCPRs and trend analysis reporting related to commercial product complaints.

Escalates Critical and Major Complaints timely and presents them to senior management.

Collaborates cross functionally and geographically with stakeholders to ensure alignment of complaint management process.

Develops an effective working relationship with Gilead Sites, CMOs, and Patient Safety.

Supports development and implementation of strategic Quality assurance programs and initiatives.

Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.

Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).

Develops solutions to more complex problems, identifies variance from accepted practice, and evaluates impact as necessary.

Provides guidance and technical knowledge to more junior staff, monitors the performance of daily tasks.

Normally receives no instruction on routine work, general instructions on new assignments.

Basic Qualifications

Bachelor’s degree and 4+ years of relevant experience in a GMP environment related field; OR

Master’s degree and 2 + years of relevant experience

Prior experience in pharmaceutical industry is preferred

Preferred Qualifications

Demonstrates proficiency in Good Manufacturing Practices (GMPs).

Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards.

Demonstrates thorough knowledge of FDA/EMEA standards and quality systems and the interface with other functions like manufacturing, distribution and maintenance.

Demonstrates strong verbal, technical writing and interpersonal skills.

Demonstrates proficiency in Microsoft Office applications.

Gilead Core Values

Integrity (Doing What’s Right)

Inclusion (Encouraging Diversity)

Teamwork (Working Together)

Excellence (Being Your Best)

Accountability (Taking Personal Responsibility)

Job Description

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

Specific Job Responsibilities

• Responsible for clinical and commercial complaint investigations.

• Responsible for tracking and trending of complaints across all Gilead Sciences sites and presents data periodically for Quality Management Review

• Leads and co-ordinates complex complaint investigations, including development and implementation of corrective actions.

• Interfaces with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorates. Prepares and presents Complaint data to the regulatory agency inspections.

• Writes and/or implements changes to controlled documents (e.g., SOPs, investigational protocols etc.) as needed.

• Supports Annual Product Quality Reviews, CCPRs and trend analysis reporting related to commercial product complaints.

• Escalates Critical and Major Complaints timely and presents them to senior management.

• Collaborates cross functionally and geographically with stakeholders to ensure alignment of complaint management process.

• Develops an effective working relationship with Gilead Sites, CMOs, and Patient Safety.

• Supports development and implementation of strategic Quality assurance programs and initiatives.

• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.

• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).

• Develops solutions to more complex problems, identifies variance from accepted practice, and evaluates impact as necessary.

• Provides guidance and technical knowledge to more junior staff, monitors the performance of daily tasks.

• Normally receives no instruction on routine work, general instructions on new assignments.

Basic Qualifications

• Bachelor’s degree and 4+ years of relevant experience in a GMP environment related field; OR

• Master’s degree and 2 + years of relevant experience

• Prior experience in pharmaceutical industry is preferred

Preferred Qualifications

• Demonstrates proficiency in Good Manufacturing Practices (GMPs).

• Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards.

• Demonstrates thorough knowledge of FDA/EMEA standards and quality systems and the interface with other functions like manufacturing, distribution and maintenance.

• Demonstrates strong verbal, technical writing and interpersonal skills.

• Demonstrates proficiency in Microsoft Office applications.

Gilead Core Values

• Integrity (Doing What’s Right)

• Inclusion (Encouraging Diversity)

• Teamwork (Working Together)

• Excellence (Being Your Best)

• Accountability (Taking Personal Responsibility)

The salary range for this position is: $102,085.00 - $132,110.00. 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.

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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 [e-mail] 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 apply via the Internal Career Opportunities portal in Workday.

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Job Requisition ID R0045442

Full Time/Part Time Full-Time

Job Level Associate

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