Senior Quality and Computer Systems Validation
3 weeks ago
Job Description
SecureGen is seeking a Senior Quality and Computer System Validation (CSV) Associate that provides quality and compliance oversight for GxP computerized systems across SecureGen internal and pharma clients hosted implementations. In this role you will be responsible for assuring that GxP systems are validated in compliance with current regulations and SecureGen’s risk-based computer system validation procedures. Must have data integrity, computer system validation, change management, risk management, issue management and software development lifecycle knowledge.
Responsibilities
- Lead all quality initiatives for both internal and client hosted computer system implementations as a Computer System Validation Domain Process Owner
- Drive strategy and direction of the development of standards and procedures and aligning with key partners on implementation of validation requirements.
- Provide guidance on and interpretation of GxP guidance and regulations of computerized systems, electronic records, electronic signatures and data integrity requirements (21 CFR Part 11, EU Annex 11).
- Provide computer system validation quality assurance oversight for computerized systems used in Drug Development clinical functional areas including - Data Sciences, Biomarkers and Clinical Pharmacology.
- Provide guidance for the implementation and validation of computerized systems, including the review and approval of validation deliverables and change controls.
- Supervise quality initiatives, including fostering a commitment to Quality in individuals and a culture of quality within SecureGen.
Qualifications
- Bachelor’s degree with 5+ years of experience with implementing and validating regulated clinical systems
- Extensive understanding of GAMP 5, SDLC, ICH guidelines, 21 CFR Part 11, Annex 11, and Data Integrity concepts and controls for computerized systems including good documentation practices.
- Exceptional verbal, written, interpersonal, organizational and project management skills.
- Excellent organizational and project management skills.
- Able to lead and mentor junior/senior staff and cross functional teams.
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