Senior Manager, Quality Assurance

Regulatory Toolkit; Foster City (CA); Presencial; USD 158.000 - 204.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision insurance

Life insurance

Discretionary bonus

Stock-based long-term incentives

Descripción de la vacante

Gilead Sciences Inc. in Foster City seeks a Sr. Manager, Quality Assurance to lead QA strategy and ensure cGMP compliance across manufacturing and QC operations from startup through steady-state production.

You will mentor Quality personnel, review investigations, approve GMP documentation, and partner with Manufacturing, Process Development, and Regulatory teams while maintaining Health Canada/FDA standards.

Formación

• 8+ years of experience in a GMP environment
• Hands-on experience supporting biologics, GMP Manufacturing and QC operations
• Strong cross-functional collaboration and communication skills
• Knowledge of QA principles and regulatory expectations

Responsabilidades

• Provide QA strategy and oversight for GMP Manufacturing and QC operations.
• Review investigations (OOS/OOT/deviations) and ensure CAPA
• Approve GMP documentation and drive continuous improvement of quality processes
• Lead and mentor QA personnel supporting GMP operations
• Coordinate with Manufacturing, QC, Process Development, Engineering, Supply Chain, and Quality management

Conocimientos

QA leadership

GMP knowledge

Regulatory compliance

Quality systems

Educación

BS/BA in related field

MS in related field

GMP related certification

Descripción del empleo

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

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

As the Sr. Manager, Quality Assurance, you will hold a key role accountable for strategizing and delivering Quality Assurance objectives supporting the Foster City Manufacturing New Chess Facility (NCF). This role will support startup, operational readiness, and steady-state manufacturing and analytical operations while ensuring alignment with manufacturing, digital, quality control, and compliance priorities.

This is a site-based, individual contributor role.

Key Responsibilities:

GMP Operations Quality Oversight

• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements for GMP Manufacturing and QC testing operations through the product lifecycle from master cell bank to drug product.
• Provide Quality Assurance strategy and oversight of external QC laboratories, ensuring method lifecycle activities (qualification, verification, and validation) are executed in compliance with cGMP, ICH, and internal quality standards, with appropriate review and approval of protocols, reports, and methods.
• Reviews and approves laboratory investigations (e.g., OOS/OOT/deviations) conducted by contract partners, ensuring thorough root cause analysis, robust corrective and preventive actions (CAPA), and aligned decision-making impacting product quality and disposition.
• Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews
• Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met.
• Implements and maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
• Responsible for final release of manufactured products
• Applies Quality Risk Management principles to oversee risk assessments in collaboration with Manufacturing and QC operations.
• Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
• Works extensively with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications.
• May participate in the development of training programs regarding all aspects of producing quality products.
• Serves as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products. May lead compliance audits as required.
• Interfaces with contract manufacturers to address and resolve more complex product/process performance issues.
• Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes.
• May interface with regulatory agencies as required.

Compliance, Audits & Inspections

• Participate in internal GMP audits and routine walk-throughs of Manufacturing, QC, and Warehouse areas to support continuous improvement.
• Support during regulatory inspections and internal audits.
• Monitor regulatory requirements and proactively assess potential operational compliance risks.

Quality Systems & Documentation

• Approve GMP documentation including risk assessments, procedures, master batch records, specifications, and analytical methods. Drive continuous improvement of quality processes supporting GMP operations.

Leadership & Collaboration

• Provide leadership, development, and mentoring for Quality personnel supporting GMP operations.
• Partner cross-functionally with Manufacturing, QC, Process Development, Engineering, Supply Chain, and Quality management on corporate and site initiatives.
• Lead or support Quality-related operational projects and improvement initiatives.
• Provide on-call Quality Assurance support to Manufacturing and QC operations, as required.
• Use risk-based decision making to prioritize tasks and ensure product quality.
• Maintain strong working knowledge of Health Canada, FDA, and global GMP expectations.

Knowledge:

• Demonstrates in-depth knowledge of GMPs and/or GLPs.
• Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Demonstrates keen understanding of international quality systems regulations to adopt best in class systems/processes, and drive continuous improvement initiatives.
• Demonstrates knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements.
• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred.
• Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is preferred.
• Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred.

Requirements:

• 8+ years of experience in a GMP environment related field and a BS or BA OR
• 6+ years of relevant experience in a GMP environment related field and a MS OR
• 2+ years of relevant experience in a GMP environment related field
• Hands-on experience supporting biologics, GMP Manufacturing and QC operations is required.
• Strong understanding and experience of materials management, manufacturing and analytical methods and testing systems within a GMP environment.
• Strong cross-functional collaboration and communication skills are required.

People Leader Accountabilities:

• Create Inclusion -knowingthe business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employeesare receivingthe feedback and insight needed to grow,developand realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizationalobjectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is: $157,590.00 - $203,940.00. 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:

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 theKnow 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.