Work Flexibility: Onsite As the Manager, Quality Assurance , you will lead quality assurance activities that support product quality, process performance, audit readiness, and continuous improvement across site operations. Working closely with Operations, Global Quality, Regulatory Affairs, and supplier partners, you will help ensure quality systems remain effective, compliant, and aligned with business objectives. This role is Onsite in Mahwah, New Jersey . What You Will Do Lead the Quality Assurance team, providing technical guidance and quality oversight across manufacturing and operations, supports functions to drive continuous improvement and compliance. Partner with site leadership to ensure products consistently meet customer expectations, regulatory requirements, and applicable quality standards. Develop, coach, and retain a high-performing team while fostering a culture of inclusion, accountability, collaboration, and employee engagement. Drive quality system compliance by partnering with functional leaders to establish, communicate, and maintain quality standards, requirements, and responsibilities. Lead site readiness activities and support internal, corporate, notified body, FDA, and other regulatory audits and inspections. Oversee the management of nonconforming products, product and process deviations, risk assessments, corrective actions, and preventive actions to ensure effective resolution and compliance. Monitor and improve Quality performance indicators, including NCR, CAPA, compliance, and operational quality metrics, and implement corrective actions for adverse trends. Support the development and execution of local and global Quality Operations strategies that improve product quality, operational efficiency, risk management, and regulatory compliance. <
Manager, Quality Assurance
Role overview
Job description
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
Job Responsibilities:
- Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements - supervises QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
- Participates in writing or suggesting changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met.
- 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.
- Works closely 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.
- May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
- Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes.
- May assist or lead compliance audits as required. May interface with regulatory agencies as required.
- Interfaces with contract manufacturers to address documentation and compliance issues.
Basic Requirements:
- 7+ years of relevant experience in a GMP environment related field and a BS or BA.
- 5+ years of relevant experience and a MS.
Preferred Skills:
- Proficient in GMPs and/or GLPs.
- Proficient in application of QA principles, concepts, industry practices, and standards.
- Demonstrates ability to effectively manage multiple projects/priorities.
- Has proven analytical and conceptual skills.
- Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
- Demonstrates excellent verbal communication, technical writing and interpersonal skills.
- Demonstrates working knowledge and good proficiency in Microsoft Office applications.
- Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is beneficial.
- Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 ApplicantAccommodations@gilead.com 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
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
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 apply via the Internal Career Opportunities portal in Workday.
What they are looking for
Skills & requirements
Qualification
Basic Requirements: 7+ years of relevant experience in a GMP environment related field and a BS or BA; 5+ years of relevant experience and a MS
Hiring company
Gilead
Explore this employer's active roles, salary signals and company profile on Jobiba.
Keep exploring
Similar active roles
Fresh roles matched to this title and market.
We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Position Summary Leads and manages the QA team by setting strategic objectives and ensuring the implementation of effective quality assurance processes. Collaborates with cross-functional teams to define testing requirements, develop test plans, and ensure timely and thorough testing of software products. Analyzes testing metrics, provides reports to stakeholders, and drives continuous improvement in QA practices to deliver high-quality and reliable software solutions. Required Qualifications 5-7 years work experience in a claims or claims audit position. Adept at execution and delivery (planning, delivering, and supporting) skills Adept at business intelligence Adept at problem solving and decision making skills Adept at collaboration and teamwork Adept at growth mindset (agility and developing yourself and others) skills Preferred Qualifications 5+years of quality management, audit, compliance or operational quality experience Adept at growth mindset (agility and developing yourself and others) skills Demonstrated experience using quality metrics, KPIs, dashboards, and business intelligence tools to identify trends and present recommendations to senior leadership Experience leading root-cause analysis, corrective and preventive action (CAPA), risk mitigation, and co
Our vision is to transform how the world uses information to enrich life for all . Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever. The US Expansion Construction team is driving some of the most significant semiconductor manufacturing projects in the United States, including two high-volume manufacturing facilities in Boise, Idaho (ID1 and ID2) and a greenfield manufacturing facility in Clay, New York. Our team partners across engineering, construction, commissioning, and operations to deliver world-class facilities that support the future of technology and innovation. As the ID Quality Assurance Lead, you will be a key member of the US Expansion Strategic Programs team, reporting to the ID Sr. Commissioning Manager. In this highly visible role, you will lead quality governance across major capital projects, ensuring compliance, commissioning readiness, documentation integrity, and operational turnover excellence. You will serve as the primary owner-side quality leader, collaborating with contractors, vendors, inspection agencies, operations teams, and regulatory stakeholders to deliver successful project outcomes. Responsibilities: Lead quality governance, performance metrics, audit programs, reporting, and continuous improvement initiatives across Idaho capital projects Oversee contractor and vendor quality execution, including quality plans, inspections, testing, material verification, hold points, and compliance with project requirements Manage special inspection programs, testing agency coordination, regulatory interfaces, and turnover-ready quality documentation Align construction quality activities with co
$210.4K – $272.3K/yr
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 At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. The Director, Quality Assurance – GMP Operations provides senior Quality leadership and direct quality oversight of Manufacturing and
About the Team At OpenAI, the User Safety & Risk Operations (USRO) team helps protect our products and users from abuse, fraud, safety risks, and other forms of misuse. We operate at the front line of real-world safety and risk management, translating user and operational signals into timely decisions, effective interventions, and improvements to our systems. This role sits on a team focused on building operational capacity for new, ambiguous, and fast-moving company priorities. The team defines what needs to be built, creates the operating model to support it, and works with partner teams to make the work scalable and durable over time. About the Role We are looking for a senior program manager to build the safety, quality, and risk operations supporting a new category of consumer devices. You will translate ambiguous product risks and evolving requirements into practical operating models, workflows, escalation paths, launch-readiness plans, and cross-functional decision-making. This is a foundational role: the systems you build will shape how OpenAI launches, monitors, and improves a new category of consumer devices safely at scale. You will help establish how potential safety incidents, product-quality concerns, sensitive customer escalations, privacy-sensitive issues, and other emerging device risks are identified, investigated, resolved, and incorporated into product and operational improvements. You will turn incomplete requirements into practical workflows, decision rights, launch plans, quality controls, measurement, and durable ownership. The role centers on program building, operational judgment, and execution. We welcome candidates from product safety, quality assurance, regulatory operations, technical program management, healthcare, medical devices, aerospace, consumer technology, and other environments involving complex products or regulated risks. Direct consumer-hardware experience is helpful but not required. The strongest candidates learn unfam
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. 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 Kite and help create more tomorrows. Job Description Key Responsibilities Manage commercial pharmaceutical labeling projects from initiation through implementation. Coordinate labeling activities across Regulatory Affairs, Quality Assurance, Supply Chain, Manufacturing, Packaging Engineering, and external vendors. Lead artwork development, review, approval, and implementation activities. Manage project timelines, risks, priorities, and deliverables to ensure on-time execution. Review and approve artwork proofs, printer proofs, and packaging components for accuracy and compliance. Maintain labeli
🔔 Get job alerts
New Manager, Quality Assurance jobs in United States - California - Foster City, United States, straight to your inbox.
No spam · Unsubscribe anytime