Senior Manager, Quality – Combination Products, Compliance

Gilead Sciences, Inc.; La Verne (CA); On-site; USD 139,000 - 182,000; Full time

Job summary

An established industry player is seeking a Senior Manager for Quality in Combination Products. This role is pivotal in ensuring compliance and advancing innovative combination products like vial kits and pre-filled syringes. The ideal candidate will leverage extensive experience in quality management systems and medical device regulations to enhance processes and drive improvements. Join a dynamic team dedicated to maintaining the highest standards in quality and compliance, where your expertise will directly contribute to the success of groundbreaking products that improve patient outcomes. This is a fantastic opportunity to make a significant impact in a forward-thinking organization.

Benefits

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Company-sponsored medical insurance

Dental insurance

Vision insurance

Life insurance

Qualifications

• 8+ years of experience in QA with a Bachelor's or 6+ years with a Master's.
• Strong knowledge of medical device manufacturing and quality principles.

Responsibilities

• Monitor and ensure compliance with global medical device regulations.
• Lead process mapping and change for QMS documentation and standards.

Skills

Quality Management System (QMS)

Medical Device Regulations

Project Management

Process Improvement

Risk Management

Six Sigma

Education

Bachelor's degree in Science or Engineering

Master's degree in Science or Engineering

Tools

ISO 13485

ISO 14971

IEC 62366

Job description

Senior Manager, Quality – Combination Products, Compliance

Locations: United States - California - La Verne

Time Type: Full time

Posted on: Vor mehr als 30 Tagen ausgeschrieben

Job Requisition ID: R0041876

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 at the 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 SOPs, job aids, and WIs.
• 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.

The salary range for this position is: $139,995.00 - $181,170.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. 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: Gilead Benefits.

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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.