Senior Manager, Quality – Combination Products, Compliance

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
 

This role offers an exciting and challenging opportunity that will be key to Gilead's success as we advance new combination products, such as vial kits and pre-filled syringes, to market. You will be a key Quality leader responsible for managing compliance for combination products compliance at Gilead La Verne site.

We are looking for an experienced Quality professional to ensure that our QMS provides comprehensive support of these combination products.

Roles/Responsibilities:

• Monitor medical device standards for quality management system (QMS) updates to ensure adherence to global regulations

• Monitor device/combination product enforcement trends in the industry and develop recommendations and action plans for QMS improvement

• Participate in external industry committees and ensure compliance with applicable medical device and combination product regulations

• Participate in the development and rollout of device standards lists by product types and families

• Coordinate and lead the process mapping and change for the development, revision, and maintenance of applicable department SOP’s, job aids, and WI’s

• Engage with stakeholders across various functions when creating/revising QMS processes.

• Lead gap assessments against new regulations and relevant inspectional observations, and perform impact assessments as required

• Participate in evaluations of medical device reports (MDRs) and provide documented justifications for reportable and non‑reportable regulatory decisions.

• Support medical device and combination product inspectional readiness activities and regulatory inspection responses

• Assist with internal and external audits and inspections, acting as an SME and providing follow-up support as required

• Support combination product complaints process and investigations and relay findings to the design and development team

• Evaluate information from a QA technical perspective to ensure appropriate analysis and risk prioritization

• Compile and analyze data, metrics, and trends associated with combination product processes.

• May manage Quality personnel (contract or FTE), including organizing and prioritizing daily tasks, conducting training, and writing performance reviews

Knowledge, Experience, and Skills:

• 8+ years of relevant experience with a Bachelor’s degree in a Science or Engineering field; or 6+ years of relevant experience with a Master’s degree in a Science or Engineering field

• Medical device manufacturing, testing or QA experience is essential. Experience with combination devices (e.g., autoinjectors, co-packaged kits, pre-filled syringes) is preferred

• Demonstrated in-depth knowledge of Quality principles, concepts, industry practices, and standards

• Familiarity with end-to-end lifecycle QMS management

• Strong project management and process improvement skills

• Demonstrated keen understanding of U.S. and international quality systems regulations to adopt best-in-class systems and drive continuous improvement initiatives

• Knowledge of applicable standards, including 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62366

• Preferred knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistics

• Knowledge of ISO 14971 Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and/or FMEA is preferred.

• Certification by ASQ (such as CQA, CQE, or CQM) or other industry-recognized professional organizations is preferred.

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.

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 [email protected] for assistance.

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