Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Foster City

Description

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.


Job Description

Specific Responsibilities:

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.


Meet the worldwide QA Team: https://qualityassurance-careers.gilead.com/


- Manages QA activities, including organizing and prioritizing daily tasks, related to new product launches, technology transfers and validation for commercial drug product (solid dosage, steriles), packaging and labeling.
- Serve as project lead within the QA function.
- Determines corrective actions based on investigative findings and in consideration of the long-term impact of decisions.
- Works on problems that are moderately complex in nature where analysis of situations involved in-depth and detailed evaluation of various factors.
- Provide batch record review and final disposition for batches manufactured to support validation activities.
- Interface extensively with internal stakeholders and contract manufacturers to address and resolve complex product and process issues.
- Participates in developing Standard Operating Procedures to ensure quality.
- Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
 


Essential Functions:


- Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
- 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.
- 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 writing of annual product reviews and 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


Knowledge, Experience & Skills:

Essential:


- 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.
- 8+ years of experience in a GMP environment related field and a BS or BA.
- 6+ years of relevant experience and a MS.


Desirable:


- Requires a thorough understanding of the relationship between quality, technical, regulatory and business functions in the pharmaceutical industry.
- Previous CMC development experience is helpful. Must be able to work independently to resolve complex issues and negotiate best solutions with some direct supervision.
- Exercises judgment within defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Experience in solid dose manufacturing is strongly desirable.

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: https://gilead.avature.net/Gilead


About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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.


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 careers@gilead.com for assistance.


For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ 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.

About the company

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 of more than 8,000 people 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 23 marketed products that are benefiting millions 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.

Today, Gilead's research and development effort is the largest it has ever been evaluating compounds with the potential to become the next generation of innovative therapies for HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases and cardiovascular conditions. The commercial success of Gilead's portfolio of 23 products has provided the company with the vital resources to support the development of new therapeutic advancements.

Working at Gilead provides you with plenty of opportunities for career advancement in a growing and agile environment while working with highly respected teams.

We would like to invite you to be a part of an organization that has helped millions of people around the world live healthier and more fulfilling lives

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