Senior Manager, Quality Assurance (GMP Operations) at GILEAD REMNANT PTE LTD

Foster City, California, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Sep, 26

Salary

203940.0

Posted On

15 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Compliance, Quality Assurance, Quality Control, Batch Record Review, Risk Management, CAPA, Computer System Validation, Six Sigma, DMAIC, HACCP, FMEA, Internal Auditing, Regulatory Interaction, Biologics Manufacturing, Method Validation, People Leadership

Industry

Biotechnology Research

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 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. As the Sr Manager Quality Assurance – GMP Operations at Gilead, you will provide Quality leadership and direct quality oversight of Manufacturing and Quality Control (QC) at the Foster City site. This role ensures GMP compliance through design, startup, and operation of a new, state-of-the-art Single Use DS Biologics Manufacturing facility and QC Laboratory in Foster City, CA. The position partners closely with Manufacturing and QC teams to enable compliant, risk-based decision making and continuous improvement while maintaining patient safety and product quality. This is a site based role at our facility in Foster City, CA. Knowledge: Demonstrates in-depth knowledge of GMPs and/or GLPs. 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 drive 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. Specific Job Responsibilities: Manages, prioritizes, and participates in batch record review and release activities, including review of manufacturing, environmental monitoring, and quality control data for in-process and finished products. Responsible for final release of manufactured products. Provide Quality Assurance oversight of external QC laboratories, ensuring method lifecycle activities (qualification, verification, and validation) are executed in compliance with cGMP, ICH, and internal quality standards, with appropriate review and approval of protocols, reports, and methods. Review and approve laboratory investigations (e.g., OOS/OOT/deviations) conducted by contract partners, ensuring thorough root cause analysis, robust corrective and preventive actions (CAPA), and aligned decision-making impacting product quality and disposition. Manages, prioritizes, and reviews quality control data for method establishment, qualification/validation, and transfer. Apply Quality Risk Management principles to oversee risk assessments in collaboration with Manufacturing, and QC operations. Participates in authoring, reviewing, and approving changes to standard operating procedures, specifications, forms, and other controlled documents to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs). Participates in and oversees design and planning of new biologics manufacturing facility and QC laboratory. Participates in site inspection readiness activities and internal audits. Participates in continuous improvement initiatives. Partner with internal partners to ensure resolution of quality issues. Participates in review/approval of Deviations, CAPAs, and Change Management records as required. Works on problems that are moderately complex in scope where analysis of situations or data requires in-depth evaluation of various factors. Considerable judgement is required in resolving problems and making scientific routine recommendations. Specific Education & Experience Requirements: 8+ years of experience in a GMP environment related field and a BS or BA OR 6+ years of relevant experience and a MS OR 2+ years of relevant experience and a PhD Experience across broad areas of Quality Assurance and/or Quality Systems. Experience with interacting with regulatory agencies. Excellent interpersonal, verbal, and written communication skills. Knowledge of Risk Management tools (e.g., HACCP and FMEA) People Leader Accountabilities: Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: $157,590.00 - $203,940.00. 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: 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. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Responsibilities

Provide quality leadership and oversight for Manufacturing and Quality Control at the Foster City site, ensuring GMP compliance for a new biologics facility. Manage batch record reviews, product release, and oversee external QC laboratories and risk assessments.