What are the responsibilities and job description for the Senior QA Manager, Computer System Validation position at Bayside Solutions?
Senior QA Manager, Computer System Validation (CSV QA)
W2 Contract
Salary Range: $145,600 - $166,400 per year
Location: Redwood City, CA - Hybrid Role
Duties and Responsibilities:
- Serve as the Computer System Validation (CSV) QA subject matter expert and provide guidance on and interpretation of global GxP guidance and regulations of computerized systems, electronic records, electronic signatures, and data integrity requirements (21 CFR Part 11, EU Annex 11).
- Provide QA oversight for CSV activities for internal and external electronic systems, ensuring that CSV activities comply with global regulatory requirements (FDA, GAMP) and internal SDLC standards.
- Implement best practices for data governance/integrity and ensure that all systems meet GxP compliance requirements.
- Responsible for Quality oversight of Data Integrity and Computer System Validation activities.
- Review and approve CSV deliverables, GxP change management requests, and quality records (e.g., Deviations and CAPAs) to ensure adherence to Quality requirements.
- Lead QA audits and/or assessments for supplier qualification or requalification of electronic system service providers.
- Support process improvement efforts for computerized system policies, procedures, and system validation processes.
- Collaborate across functions and within Quality to identify areas of improvement and implement enhancements.
- Provide guidance to cross-functional teams; educate and train as necessary on a risk-based approach for deployment of GxP systems.
- Support Inspection Readiness initiatives, as well as providing support during partner audits and regulatory body inspections.
Requirements and Qualifications:
- 7 years of relevant industry experience in biotech/pharma
- Extensive understanding of 21 CFR Part 11, Annex 11, and Data Integrity concepts and controls for computerized systems
- In-depth knowledge of GAMP 5, software development, lifecycle methodologies, and current industry best practices
- Must have broad GxP electronic system experience. Clinical Quality Assurance/Compliance experience in a Bio-pharma sponsor organization is preferred.
- Expertise in 21 CFR Part 11 and EU Annex 11 regulations, data integrity, and GAMP5 concepts, applications, and best practices
Preferred Qualifications:
- Hands-on experience in implementing and maintaining data integrity controls
- Experience supporting regulatory inspections and audits.
- Experience working with all levels of management and consulting with key business stakeholders. Ability to influence greater outcomes.
- Possesses strong written and verbal communication skills
Desired Skills and Experience
GxP electronic systems, Computer System Validation, 21 CFR Part 11, EU Annex 11, GAMP 5, software development, SDLC, Clinical Quality Assurance, Clinical Quality Compliance, data integrity
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
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Salary : $145,600 - $166,400
