Product Quality Lead

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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

The primary responsibility for this position is to establish phase appropriate product specifications for Gilead’s clinical and commercial products. In addition, this position is responsible for end to end product quality strategy and serves as the QA main point of contact on the PDM Product Strategy Team(s). The position holds a scientific and technical understanding of drug development and commercialization and able to provide effective quality oversight and feedback for their assigned program(s) by liaising between the Product Strategy Team, Manufacturing, and Analytical functions, Supply Chain, RA CMC, and the wider PDM Quality organization.

Job Functions

• Expert in analytical control systems, assuring network-wide harmonization of control systems by proactive lifecycle management, technical leadership and ownership.
• Provide technical oversight of product specification setting and justification based on scientific approach. Deep understanding of analytical methods (development, validation, transfer, and monitoring) and product (process development, CQA analysis, stability, comparability, etc).
• Ability to evaluate Global product filing strategies with core PDM Team for implementation.
• Provide timely support for health authority interactions on the product, authorship / review (as needed) relevant health authority information requests for in-process controls, process development (comparability), method validation, specifications, reference standard, and stability sections of regulatory submissions.
• Build internal knowledge and capabilities on product control strategies. Proactively share expertise with other functional groups to generate alignment and improvement opportunities.
• Accountable for end-to-end quality compliance of the assigned product / program, which include but not limited to providing strategic leadership and direction for quality and compliance activities and owns the overall product risk log.
• Serve as the primary Quality representative in the PDM meeting.
• Lead Product Quality Teams (PQT) supporting the product / program, and ensure visibility and communication of strategy, key project timelines and CMC milestones.
• Monitor and review cross-functional process and product data to identify trends to ensure significant quality and compliance risks are identified, mitigated and, if necessary, escalated in a timely manner.
• Review and approve the strategy for change control(s) impacting the product / program lifecycle.
• Provide technical oversight of Major and / or Critical Deviations, CAPAs, Biological Product Deviation and Complaints.
• Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist with regulatory communications as needed (e.g. responses to agency information requests, the Notified Body Option).
• Provide oversight for changes to drug substance and drug product CMC details.
• Accountable for PAI / PLI readiness and supports Gilead PAI / PLI inspection preparation efforts and post-PAI / PLI follow up as a Subject Matter Expert with Quality representatives at CXO(s) and Gilead Sites.
• Support drug substance and drug product technology transfer, and new product launches.
• Participate in drafting commercial Annual Product Quality Review (APQR) and review / approve Gilead and CMO APQRs for commercial products.
• Accountable for medical device / combination product quality compliance : engage / liaise with medical device product engineering, development, and quality teams.
• Facilitate Analytical Strategy (stability strategy, specifications, Critical Quality Attributes).
• Perform work that requires independent decision making and the exercise of independent judgment.
• Serve as the delegate for direct manager, as needed, for meeting and decision making.

Knowledge, Experience And Skills

Basic Qualifications

OR

OR

Preferred Qualifications

Salary

The salary range for this position is : $210,375.00 - $272,250.00. 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

Benefits

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.

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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 under the 503 Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Act of 1974, and the 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 EEO protections, please view the ‘Know Your Rights’ poster.

NOTICE : EMPLOYEE POLYGRAPH PROTECTION 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.

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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.

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