- 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.
- 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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Sr. Manager Quality – Combination Products, Compliance - Foster City, United States - Gilead Sciences
Description
Job Description
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.
We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.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. Join Gilead and help create possible, together.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:
Knowledge, Experience, and Skills:
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The salary range for this position is: $154, $199, 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*.
