Associate Director, Quality Assurance
Associate Director, Quality Assurance
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. Gileads 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 companys five core values. Thats 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
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/
Associated Director, Quality Assurance
Gilead in Foster City is seeking a talented QA professional to support our development and commercial businesses. This role will focus on Quality projects across the organization including Gilead enterprise systems support (developing and maintaining procedures, business processes, user requirements, etc), manage and administer local systems, develop training materials and provide instructor-led training for local systems and selected enterprise systems, dispositioning materials provided by external collaborators for use in the manufacture of Gilead products, and managing CMC changes with external collaborators. Role is accountable for both personnel and task management and may manage QA personnel. The role will be based in Foster City, CA.
- Manages QA personnel, including organizing and prioritizing group tasks, performing training, and writing performance reviews.
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
- Participates in developing Standard Operating Procedures to ensure quality across internal and CMO operations
- Maintains Quality Assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines.
- Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- Ensures that inspections are conducted of raw materials, ingredients, and product according to specifications
- Ensures compliance with current Good Manufacturing Practices(GMPs) and Good Laboratory Practices (GLPs).
- Leads compliance audits as required. Interfaces with contract manufacturers to address documentation and compliance issues.
- May interface with regulatory agencies as required.
- Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
- Specialize in transferring and driving quality initiatives across internal and external organizations - this would include areas like process improvement, quality technical management, etc.
Knowledge and Skills
- Demonstrates in-depth knowledge of Good Manufacturing Practices
- (GMPs) and/or Good Laboratory Practices (GLPs).
- Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
- Demonstrates keen understanding of Computer Systems Validation and ICH Guidelines.
- Demonstrates excellent verbal, written and interpersonal communication skills.
- Demonstrates knowledge of Six Sigma, Define-Measure-Analyze- Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical.
- Demonstrates working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)).
- Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry- recognized professional organizations.
- Demonstrates strong ability to drive programs forward by influencing and supporting contributors and across organizational levels.
- 10+ years of relevant experience in a GMP environment related field and a Bachelor's degree in science or related fields.
- 8+ years of relevant experience and a MS.
- Knowledge and experience in quality assurance in a highly regulated manufacturing environment.
- Prior experience in the pharmaceutical industry and people management experience.
- Experience with data analytics, data extraction and creating metrics and useful dashboards
- Experience with Quality Assurance and pharma Industry software and systems.
- Ability to manage and lead projects in a cross functional environment.
- Experience creating workflows and changes management for quality systems.
- Strong critical thinking skills
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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 firstname.lastname@example.org 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.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Associate-Director--Quality-Assurance_R0017386-2
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