Sr Specialist, Quality Systems

Role Summary

Sr Specialist, Quality Systems at Gilead. Lead change management initiatives, develop and improve quality system processes, and ensure compliance with cGMPs and regulatory expectations. Collaborate with cross-functional teams to manage change controls related to manufacturing and related systems, while providing guidance to junior staff.

Responsibilities

• Independently and proactively initiate and drive the planning, execution, and completion of change management projects
• Develop and implement strategies to mitigate risks within the change management process and change control system
• Facilitate and present at cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS and regulatory expectations
• Manage change controls related to manufacturing product, process, equipment, facility, and computerized systems
• Develop, deliver, and improve the change management program for various levels of the organization, ensuring training effectiveness
• Review, initiate, complete, and document critical, major, and minor change controls, managing local and global change controls and related activities
• Navigate complex change review discussions, document decisions and evaluations, and follow up as needed
• Support management and monitoring of change records and maintenance of tracking tools/databases
• Support management review through development and generation of quality system metrics and trending
• Collaborate with Change Management Business Process Lead and support team to enhance QMS processes
• Support maintenance and improvement of quality systems processes as needed
• Work with operating entities and internal clients to ensure follow-up of change tasks
• Participate in compliance audits as required
• Maintain programs to ensure high quality products and compliance with cGMPs
• Write and/or implement changes to controlled documents (SOPs, Specifications, Methods, etc.) and provide guidance to junior staff

Qualifications

• Demonstrates proficiency in GMPs and/or GLPs
• Demonstrates proficiency in QA systems principles related to change management
• Ability to manage multiple complex projects and priorities simultaneously
• Ability to work independently
• Analytical and conceptual skills; understanding of international quality systems regulations
• Excellent verbal communication, technical writing, and interpersonal skills
• Experience with Quality Management Systems (e.g., Veeva, TrackWise, MasterControl)
• Proficiency in Microsoft Office

Education

• BS or BA with 7+ years of relevant GMP experience
• OR MS with 5+ years of relevant GMP experience

Skills

• Change management and QMS process optimization
• Quality systems documentation and regulation compliance
• Cross-functional collaboration and stakeholder management
• Data analysis and quality metrics/trending
• Training effectiveness and capability development