Director/Sr. Director, Quality Operations
6 days ago
🏢 In-office - Bay Area
Description
• Lead quality functions • Build and lead a strong QMS • Ensure compliance with regulatory requirements • Oversee all quality control and assurance activities • Collaborate on quality and compliance aspects of technology transfer • Serve as expert resource for GXP training activities • Establish and maintain KPIs for quality metrics • Develop process for product life cycle management • Stay updated on regulations and integrate them into Quality systems • Conduct internal audits and support Regulatory interactions • Collaborate with teams to address compliance issues • Champion a culture of compliance and quality excellence • Lead risk assessment activities • Develop risk management plans • Recruit, mentor, and develop quality professionals • Provide strategic direction to the quality team • Assist in developing and supporting an operating budget • Collaborate on regulatory submissions • Provide Quality review of Change Control records
Requirements
• Minimum 10 years experience in quality assurance, quality control, and/or quality operations within biotechnology industry • In-depth knowledge of global regulations governing cell and gene therapy products • Strategic thinker with ability to develop and implement quality and regulatory strategies • Keen attention to detail and ability to implement Quality Operations clearly into processes • Writing SOPs, Reviewing Protocols and Reports is important • Experience with QMS and ability to onboard, implement and maintain a validated QMS • Exceptional communication skills for mentoring and training • Experience with regulatory inspections and audits is a plus • Strong collaboration skills with a congenial attitude • Experience managing complex schedules and shifting priorities is a plus • Ability to create structure and maintain timelines in a dynamic environment
Benefits
• Comprehensive medical and other benefits • Additional incentives provided as part of the package
Apply Now
