Associate Director, Quality Engineering - Combination Products, Tech Transfer And Commercial

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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Job Description
Associate Director, Quality Engineering - Combination Products, Tech Transfer and Commercial
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 the key Quality person supporting these new product lines in the commercial stage, starting with collaborating with the design and development team on Design Transfer. We are looking for an experienced Quality professional to ensure that we have end-to-end Quality support of our Combination Products.
Roles/Responsibilities:

• Provide Quality oversight for the Commercial stage, including Design Transfer
• Create/revise/execute SOPs to support combination product quality governance in the commercial stage.
• Evaluate design changes and provide quality input to support continuous improvement initiatives.
• Stay abreast of evolving regulatory requirements and ensure commercial 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 and contract manufacturers to address and resolve complex technical related drug device combination product, process and quality issues.
• Ensure that changes to commercial products are conducted in accordance with FDA QSR/QMSR, ISO 13485, and other applicable standards.
• Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, WIs, etc.) as needed.
• Maintains expertise in both current and emerging requirements and quality trends as they relate to Pharmaceuticals, Medical Devices, and Combination Products worldwide.
• Interprets regulations and trends and recommends/executes changes to quality processes to ensure conformance and continuous improvement.
• Define quality goals for both annual and long range plans. Work with management and department personnel to achieve goals and strategic initiatives.
• Supports due diligence and internal or external audits/inspections as needed.
• Participate in annual product reviews and perform periodic review and update of DHF and RMF.
• Support complaints investigations and filter information back to the design and development team and CMOs.
• May manage Quality personnel (contract or FTE), including organizing and prioritizing daily tasks, performing training, and writing performance reviews.

Knowledge, Experience & Skills:

• Must have 10+ years of experience of relevant experience and a Bachelor's degree in a Science, Engineering or related field; or 8+ years of relevant experience and a Master's degree in a Science, Engineering or related field.
• Medical device experience preferred
• 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 keen 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: $177,905.00 - $230,230.00. 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.
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.