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.Role and Responsibilities:
Gilead Sciences is currently seeking an Sr. Manager, Quality Assurance– DCQA Parenterals Dept, in the Pharmaceutical Manufacturing and Development (PDM) organization located in Foster City, CA. The role is responsible for quality oversite of clinical development programs and batch disposition.Essential Duties and Job Functions:
Knowledge, Experience and Skills:
- Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements in support of Clinical Parenteral programs.
- 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, including master batch records, executed batch records, deviations and change controls.
- Responsible for final release of bulk manufactured products and labeled clinical supplies.
- 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 including laboratory investigations. May assist in 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.
- Demonstrates in-depth knowledge of GMPs and/or GLPs.
- Demonstrates in-depth knowledge of parenteral manufacturing.
- 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 drives 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.
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/GileadAbout Gilead:
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 Colorado Job Applicants:
The salary range for this position is:
$115,600.00 - $173,400.00
Gilead considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary.
Position is also eligible for bonus and benefits. For more information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing
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.​
For more information about equal employment opportunity protections, please view the ‘EEO is the Law'
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