Manager, Manufacturing Quality Assurance
Manager, Manufacturing Quality Assurance
United States - California - Oceanside
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
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.
- Manages MQA team providing oversight and support for clinical biologics programs and operations to ensure conformity with applicable company policies, standards, procedures, and compliance with regulatory requirements
- Supports continuous improvement efforts through the reporting, trending, and evaluation of quality metrics data with site management
- Manages and directs team to ensure effective review and management of investigations, CAPAs, change controls, analytical data, technical reports, & documents/procedures are performed
- Interface as needed with contract manufacturers/laboratories to address and resolve more complex performance or Quality issues
- Works with Process Development and Technical Manufacturing Ops teams during new product introductions to provide quality guidance for all phases of product development
- Interface with regulatory agencies as required, representing Gilead during health authority inspections
- May support the preparation and review of BLA/IND/IMPD regulatory submissions for US and worldwide health agencies
- Responsible for the hiring, mentoring, and performance management of MQA staff
- Implement and manage EHS programs within the area of responsibility and monitor the safety and environmental performance of the operations
- Participate in investigations and analyze accidents / incident that occur in the functional area and make improvements to minimize occurrence of accidents
- Assure compliance with environmental and safety regulations
Knowledge & Skills
- Demonstrates strong knowledge in Biologics or Pharmaceutical Manufacturing operations
- Demonstrates strong knowledge of Facilities/Maintenance, Automation, Equipment, and Process Validation.
- Demonstrates strong knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
- Demonstrates working knowledge of quality assurance systems, methods and procedures.
- Demonstrates knowledge of FDA / EMEA standards and quality systems regulations.
- Demonstrates audit and investigation skills, and report writing skills.
- Demonstrates strong verbal, written, and interpersonal communication skills.
- Demonstrates Strong knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
- Prior experience with ERP systems (SAP/Oracle/LIMS/Trackwise)
Typical Education & Experience
- 7+ years of relevant experience in a GMP environment related field and a BS. OR 5+ years of relevant experience and a MS.
- Prior experience in Biologics or Pharmaceutical industry is preferred.
Gilead Sciences, Inc. is a research-based biopharmaceutical 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.
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 firstname.lastname@example.org for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b
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:
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