Sr. Quality Engineer - Combination Products, QMS 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 opportunity is an exciting and challenging role that will be key to Gilead's success as we work towards bringing new combination products, such as vial kits and pre-filled syringes, to market. You will be a key Quality person supporting these new product lines in the commercial stage, starting with collaborating with the design and development team and the Gilead network on Quality Assurance related activities. We are looking for a Quality professional to ensure that we have end-to-end Quality support of our combination products. 
Roles/Responsibilities:

• Provide Quality oversight for QMS development and maintenance.

• Create/revise/execute SOPs and other controlled documents to support combination product quality governance throughout a combination product’s lifecycle.

• Provide quality input to support continuous improvement initiatives.

• Stay abreast of evolving regulatory requirements and ensure combination products comply with applicable standards.

• Maintain compliance with global Risk Management processes in accordance with ISO 14791 and other applicable standards. Work cross-functionally with Subject Matter Experts from R&D, Clinical, and Operations to ensure the risk process is applied comprehensively.

• Create and provide Quality training as needed for cross functional stake holders and CMOs.

• Develop key relationships and interface extensively with internal stakeholders to address and resolve complex technical related drug device combination product, process, and quality issues.

• Ensure that changes to combination products are conducted in accordance with FDA QSR/QMSR, ISO 13485, and other applicable standards.

• Maintains expertise in both current and emerging requirements and quality trends as they relate to Pharmaceuticals, Medical Devices, and Combination Products worldwide.

• Work with management and department personnel to achieve goals and strategic initiatives.

• Support complaints investigations and safety reporting. Work with internal stakeholders, including Patient Safety and Global QA/Complaints. Filter information back to the design and development team.

• Support field-related activities, such as corrections and removals.

• Initiate, manage and approve deviations and corrective/preventive actions.

• Supports due diligence and internal or external audits/inspections as needed.

• Support data gathering, analysis, and monitoring to support MDCP metrics for the department as well as Quality Management Review and Annual Product Quality Review requirements.

Knowledge, Experience & Skills:

• Must have 6+ years of experience in the medical device industry and a Bachelor’s degree in science or engineering related field, OR 4+ years of relevant experience with a Master’s degree.

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

• Previous experience with combination devices is preferred (i.e., Autoinjectors, co-packaged kits, pre-filled syringes).

• Quality experience in both clinical and commercial products.

• Strong project management and process improvement skills.

• Demonstrates understanding of U.S. and international quality systems regulations/standards to adopt best in class systems/processes and drive continuous improvement initiatives.

• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred.

• Knowledge of ISO 14971 Risk Management tools (e.g., Hazard Analysis / 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.

The salary range for this position is: $136,340.00 - $176,440.00. 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

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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.