Director of Quality Assurance Medicines360
Overview
Medicines360 seeks a Director of Quality Assurance to lead quality and GXP activities. This role translates the company's quality strategy into actionable policies and ensures compliance with US FDA regulations ISO 13485 and global standards. The ideal candidate will drive continuous improvement and collaborate across departments to maintain high product quality.
What You'll Do12
- 1Manage and maintain an effective Quality Management System ensuring compliance with US FDA regulations ISO 13485 and global regulatory requirements
- 2Create and oversee GXP policies SOPs and supporting documentation
- 3Lead QMS programs including change control deviations and internal audits
- 4Develop and manage supplier qualification and qualification agreements
- 5Oversee Veeva EDMS administration and act as backup system administrator
- 6Ensure inspection readiness and coordinate regulatory inspections
- 7Provide Quality and CMC guidance during product development and commercialization
- 8Supervise QA personnel and foster career development
- 9Implement continuous quality improvement strategies
- 10Maintain internal library of standards and technical publications
- 11Collaborate with external partners and manage vendor relationships
- 12Monitor regulatory changes and their impact on operations
Requirements11
- 1Minimum 10 years of Quality Assurance experience with at least 5 years in management
- 2Advanced degree preferred Bachelor level in relevant scientific discipline
- 3Expert knowledge of US FDA cGMP GLP GCP GVP QMSR ISO standards
- 4Proven experience with combination products and medical device quality systems
- 5Certification as a Designated Representative for a Wholesaler through CA State Board of Pharmacy
- 6Strong organizational and technical skills with proficiency in Veeva QMS
- 7Ability to work independently and lead cross-functional teams
- 8Excellent communication skills for internal and external stakeholder engagement
- 9Travel capability both domestically and internationally
- 10Experience with risk management principles and regulatory inspections
- 11Commitment to diversity and inclusion principles
Salary Insight
$200 - $215k per year
Location
Required Skills
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