- Serve as QPTL (Quality Product Team Lead) or QA Operational Lead (OL) for assigned programs
- Review and approve change control requests, lab investigations, deviations, and proposed corrective actions and preventative actions (CAPAs) to ensure compliance with Gilead procedures, cGMP, and all other applicable regulations
- Collaborate and escalate as necessary.
- Generate and or contribute to relevant metrics and annual product quality reports.
- Review and approve GMP facilities, utilities, and equipment changes.
- Review and approve protocols and reports (e.g., method qualification/validation, method transfer, stability, etc.) for product manufacturing and packaging.
- Generate data and contribute/participate at relevant CMC team(s).
- Interact with contract manufacturers/labs, internal manufacturing, and Analytical Operations to resolve quality issues.
- Provide oversight for API and DP Pilot Plants.
- Provide support for QP activities.
- Review existing quality workflows, perform gap assessments, and assist in identifying areas for improvement.
- Author, revise, and review standard operating procedures.
- Manages QA personnel, including organizing and prioritizing daily tasks, provides training and writing performance reviews
- Responsible for final batch review, approval and release of manufactured products.
- Review manufacturing, packaging, and labeling Drug Product batch records and in-process quality control data and assess the completeness of change controls, deviations, and test results to ensure timely disposition of drug products intended for commercial or clinical use.
- Review API/Drug Substance batch records and in-process data, assess the completeness of change controls, deviations, and test results for timely disposition of API/Drug Substance intended for commercial or clinical use.
- Interact with key stakeholders to ensure that clinical and commercial products are manufactured according to established procedures, cGMPs, and appropriate regulations.
- Maintain electronic records in Trackwise, GPLM, Oracle Enterprise Business Suite (EBS), SAP, Gilead Electronic Batch Review Systems, Veeva Vault, etc., and paper archives as needed
- Represents quality assurance in CMC Teams and/or PDM Sub teams.
- Leads a sub-team of Quality professionals supporting the product/program, and ensures visibility and communication of key project timelines and CMC milestones
- Acts in a project manager capacity to ensure:, change controls, , deviations or other issues, lab investigations, lot release status, test methods, method transfer and transfer status, stability studies, risks, metrics, regulatory inspections, audits, and other associated activities related to the product/program are accounted for and managed to timely completion.
- Supports opportunities for efficiency and capacity improvements to products/programs.
- Performs work that consistently requires independent decision-making and independent judgment and discretion.
- Learns and understands assigned programs/product's lifecycle status.
- Ability to manage multiple projects and timelines and to facilitate meetings
- Ability to track and follow up on actions requiring the team's completion.
- Ability to lead and influence a cross-functional team and global site and functional area employees to a successful project outcome.
- Objective and transparent with information
- Critical and strategic thinking skills and ability to provide pragmatic, risk-based, and phase-appropriate guidance and decision-making even when quality and compliance requirements are not well-defined.
- Awareness and application of global regulations and guidelines and industry best practices
- Ability to act as a mentor to junior staff
- Ability to provide clear perspective and rationale for thinking and functioning successfully in a dynamic environment
- Possesses experience/knowledge in laboratory controls, method validation and method transfer guidelines per FDA/EU/ICH/USP/JP guidelines
- Prior Quality leadership and technical management experience in development and/or commercial programs
- 8+ years of Biopharmaceutical or Pharmaceutical experience and a bachelor's degree in science or related fields (OR) 6+ years of Biopharmaceutical or Pharmaceutical experience and a master's degree in science or related fields (OR) 0+ years of Biopharmaceutical or Pharmaceutical experience and a PhD in science or related fields
- Experience and knowledge in quality assurance in a highly regulated manufacturing environment
- Extensive knowledge of API, OSD, and/or Parenteral
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Senior Manager, Quality Assurance - San Mateo, United States - Gilead Sciences
Description
Senior Manager, Quality AssuranceUnited 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. Gilead's 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 company's five core values. That's 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
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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
Working in QA at Gilead:
Quality Assurance delivers on Gilead's commitment to bring life-changing therapies to patients through 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.
Job Summary:
Gilead Sciences seeks a Sr. Manager, Quality Assurance, in the Pharmaceutical Development and Manufacturing (PDM) organization. The Sr. Manager provides quality and compliance activities for clinical and commercial products and programs.
Job Functions:
For additional benefits information, visit:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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 for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' 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.
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