Senior QA Manager, Biologics ASaT

Senior QA Manager, Biologics ASaT
United States - New Jersey - Parsippany

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

EQO Biologics QA Analytical Science and Technology

The team will possess a detailed understanding of Analytical QA in support of large molecule testing and manufacturing. These roles will have responsibility for supporting GMP activities at multiple external contract testing sites, internal and external method establishment, product performance monitoring, existing methods and specifications, reference standard programs, QC impacting change controls, and analytical investigation oversight.

Job Responsibilities:

Providing QA oversight to PDM Biologics Analytical Operations and QC and at Contract test partners (i.e., CTLs and CMO Labs) in support of analytical testing activities across clinical and commercial programs for external manufacturing operations.

This individual will be responsible for supporting external supply chain cGMP operations at and will, at a minimum, include:
Reviews and approves method validation and transfer related documentation and exception events.
Partners with Commercial and Development Quality Assurance Biologics colleagues to ensure testing requirements are met in a timely and compliant manner in alignment with manufacturing and release expectations.
Works Independently to perform QA team leadership for specific product campaigns manufacturing at assigned portfolio of Contract Organizations (CXOs, e.g. CMO, CTLs)
Manages daily QA team activities, leading major planned changes and exceptions, method validation and transfer related documents, deviations, investigations.
Reviews and improves existing quality procedure workflows, identifies areas of improvement for efficiency andcompliance, and leads implementation efforts in collaboration with cross-functional stakeholders.
Serves as QA project lead, leads complex quality issues and events, represents QA on Materials Review Boards and escalations as the Analytical QA expert, and authors concise quality investigation reports with appropriatecorrective action and preventive actions (CAPA).
Varying levels of knowledge in laboratory controls and method validation per FDA/EU/ICH/USP guidelines.
Acts as an Analytical QA subject matter expert in support of regulatory inspections and internal audits.
Is able to apply extensive knowledge and experience of biologics manufacturing processes to CXO QA Oversight
Supervise investigation team and resolution of cGMP or procedural compliance failures, as well as work CXO site leadership and partners to resolve compliance issues for externally produced products
Drive the completion and maintenance of CXO Quality agreements
Actively support the development, implementation, and maintenance of Gilead quality management systems, applicable SOP's and qualification activities
Ensure timely reviews of cGMP documentation, both at Gilead and CXOs
Ensure timely investigation and resolution of cGMP or procedural compliance failures, as well as work with staff from other departments to resolve compliance issues found during the Quality review
Support Quality audits of potential and/or current vendors and contract organizations
Oversee and perform training of personnel to ensure compliance and conformance to Gilead's requirements
Manage and perform day-to-day activities of the document control, including creation and/or revision, processing, routing and releasing controlled documents
Attend and/or communicate events and outcomes of issue escalation meetings/decisions
Work with project teams and PDM subteam to determine product release priorities
Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards, CXO oversight, and procedures when necessary
Lead a team to develop, apply, revise and maintain quality assurance protocols and methods for processing materials into partially finished or finished products

Knowledge, Experience and Skills:
8+ years of experience in a GxP-regulated biopharmaceutical environment with a BS (OR) 6+ years of experience in a GxP-regulated biopharmaceutical environment (OR) 0+ years of experience and a PhD
Must have practical experience working with biologics / large molecules preferably in Analytical R&D or QC
At least 3 years of experience in Supplier Quality program management.
2 years of people management
Bachelor's or Master's degree in Science, Engineering, or related discipline
In-depth understanding and application of regional regulatory requirements/guidelines specific to GxP (e.g. FDA, EU)
Proven track record with FDA, EMEA and other Health Authorities.
Comprehensive knowledge and ability to audit to GMP and ICH regulations, ISO standards
Experience as Lead Auditor and managing the audit plan a plus
Experience working with Qualified Personnel (QP) and QP Agreements
Expert in negotiating Quality Agreements, SCARs, Supplier development/improvement plan
Expert understanding and background in quality principles and tools such as risk management, process controls, key performance indicators, statistical analysis etc.
Exceptional communication skills including writing, presentation, influencing, and conflict management

The salary range for this position is: $139, $181, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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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 for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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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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