QA Analyst defining and evolving testing strategies while ensuring quality and reliability in financial solutions. Collaborating with development, product, and architecture teams in a regulated environment.
About the role
- QA/QC Director responsible for strategic leadership and operational oversight in a biotech facility. Leading QA and QC functions supporting cell and gene therapies with FDA compliance.
Responsibilities
- Lead daily QA and QC operations to ensure sustained FDA cGMP compliance
- Establish, implement, and continuously improve the Quality Management System (QMS)
- Ensure effective implementation of SOPs, policies, and quality procedures across departments
- Develop quality metrics, dashboards, and management review processes
- Support continuous inspection readiness
- Drive cross-functional quality alignment within a startup growth environment
- Provide QA oversight for manufacturing and laboratory operations
- Oversee validation and qualification activities including: Equipment, utilities, and facilities; Process validation; Computerized systems validation (CSV)
- Ensure supplier qualification processes and quality agreements are effectively implemented
- Ensure QC data integrity in accordance with ALCOA+ principles
- Lead QA/QC preparation for FDA inspections and client audits
- Serve as senior quality interface for CDMO clients
- Ensure regulatory compliance while meeting client commitments
Requirements
- Required Bachelor’s degree in Chemistry, Biology, Biochemistry, Engineering, or related scientific discipline
- 10+ years of GMP experience in biologics or sterile manufacturing
- 5+ years of progressive leadership experience in QA, QC, or combined QA/QC functions
- Experience overseeing both QA and QC operations
- Experience leading or hosting FDA inspections
- Preferred Master’s degree in scientific or engineering discipline
- CDMO or multi-client manufacturing experience
- Experience building or scaling a QMS in a startup or growth environment
- Experience with computerized systems validation (CSV)
- Familiarity with AI/ML applications in regulated environments
- Expert knowledge of FDA cGMP regulations (21 CFR Parts 210, 211, and 11)
- Working knowledge of EU GMP principles (Annex 1 familiarity preferred)
- Strong understanding of GMP laboratory operations and data integrity
- Knowledge of ALCOA+, Part 11, and GAMP 5
- Strong leadership and cross-functional collaboration skills
- Strategic decision-making and risk-based judgment
- Excellent written and verbal communication skills
- Ability to stand and walk for extended periods during facility oversight activities
- Ability to wear required PPE, including gowning for classified cleanroom environments
- Ability to access and work within GMP manufacturing and laboratory areas
- Visual acuity to review detailed documentation and electronic records
- Ability to use computers and digital systems for extended periods
- Ability to occasionally lift up to 20 pounds (documents, binders, equipment samples)
Benefits
- Equal Opportunity Employer
- Professional development opportunities
- Remote work options
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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