Sr. Manager Quality – Combination Products, Compliance

Job Description

Sr. Manager Quality – Combination Products, Compliance

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 managing Gilead combination products compliance. We are looking for an experienced Quality professional to ensure that we have a QMS that enables end-to-end Quality support of our combination products.

Roles/Responsibilities:

• Monitor external medical device standards for QMS updates to ensure compliance with all applicable global regulations.

• Monitors external device/combination product enforcement trends and provides recommendations and action plans for continuous improvement of QMS.

• Actively communicate and collaborate with stakeholders across various functions when creating/revising QMS processes.

• Manage the development and rollout of device standards lists by product types/families and ensures these are kept up to date.

• Actively participates on relevant external industry committees and ensures that existing policies are in compliance with all applicable medical device and combination product regulations.

• Lead gap assessments against new regulations and relevant inspectional observations as required and performs impact assessments.

• Supports medical device and combination product inspectional readiness activities and regulatory inspection responses as needed.

• Support combination product complaints process and investigations. Coordinate and lead root cause analyses and identification, ensuring effective corrective actions for mitigations are documented.

• Perform MDR evaluations and document written justification to support reportable and non‑reportable regulatory decisions.

• Evaluate information from a technical perspective to ensure appropriate analysis and investigations/ MDR’s are accurately assessed for risk prioritization and performed per procedures, standards, and regulations.

• Strong collaboration with Safety team, and manufacturing sites/CMOs for effective complaint handling/MDR assessments and adverse events with potential product quality issues.

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

• Support internal and external audits and inspections; ability to communicate regulatory and process positions as an SME during regulatory inspections and provide follow-up support as required.

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

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

• Support complaints investigations and filter information back to the design and development team.

Knowledge, Experience, and Skills:

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

• Medical device experience preferred.

• Demonstrated 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).

• Familiarity with end-to-end lifecycle QMS management.

• Strong project management and process improvement skills.

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

• Knowledge of applicable standards, such as 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62366, etc.

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

• 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.

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