GxP CSV Senior Manager – Associate Director
Job Title: GxP CSV Senior Manager – Associate Director
Location: Boston, MA
Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies offering life-changing therapies. Our many years of experience, subject matter expertise, comprehensive search process and genuine passion to deliver rare talent defines Brio.
As a GxP Computer Systems Validation Senior Manager/Associate Director, you will be responsible for defining, maintaining, improving, overseeing, and the execution of Computer Systems Validation within this organization as it pertains to GxP regulations.
- Manage and own the Computer Systems Validation program by authoring, reviewing, as well as approving CSV deliverables
- Collaborate with the System/Process Owners and IT team for the implementation and maintenance of GxP systems as they adhere to Data Integrity principles as they align with internal requirements and industry regulatory expectations
- Collaborate with the IT team to establish requirements for infrastructure qualifications as well as for back-up/restoration, adherence to retention schedules, and disaster recovery
- Serve as a subject matter expert for CSV during inspections and audits
- Stay up to date on current and upcoming FDA CSA (Computer Software Assurance) principles and guidelines
Position Requirements: Bachelor’s Degree Required, Computer Science Discipline
- 6+ years of CSV experience
- 10+ QA experience in a biotechnology, medical device, or pharmaceutical related environment
- Knowledge of GxP computer systems experience
- Knowledge of CSV/CSA principles and GxP regulations
- Familiarity with Clinical Data Management and ERP
We welcome the opportunity to provide a full job description upon resume review.
How to Apply:
In order to be considered for the above opportunity, simply apply via LinkedIn and include your CV.
We respond to applicants who meet our position requirements, but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network. We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent.
Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected status.