CSV Data Compliance Manager II - San Diego CA

Overview

CSV Data Compliance Manager II – San Diego, CA. Contract

Job Title:

CSV & Data Compliance Manager II

Job Type: Contract
• Length: 12 Months
•

Hours:

40 hours/week

Pay Rate: $70.00 - $79.65 per hour

Summary:

• Responsible for planning, writing, implementing and reviewing computer system validation (CSV) protocols of GxP computerized systems.
• Serve as the CSV 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.
• Collaborate with peers across Acadia on procedures relating to quality, data integrity and computer system validation.

• Support the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with global regulatory guidelines.
• Provide input into developing scope, actions, and timelines on computer system validation projects and be accountable for implementing and validating computerized systems, including reviewing and approving validation deliverables and change controls.
• Contribute expertise and provide guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participate in assessments.
• Collaborate with IT teams, vendors, business users, and internal quality compliance staff to ensure CSV activities are planned and executed in accordance with internal procedures.
• Evaluate and maintain quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements.
• Represent quality, compliance and validation controls to cross-functional business leaders when needed, including managing escalations as needed.
• Ensure quality systems procedures, systems and processes are effective and meet regulatory requirements and business needs.
• Provide support for inspection readiness activities.
• Perform periodic review analysis of validation documentation, systems and practices.
• Generate a risk-based strategy across the GxP landscape that identifies and manages issues and risks related to data integrity and a continuous improvement process to assure ongoing compliance with global DI standards.
• Other duties as assigned/required.

• Bachelor’s degree or equivalent in computer science, engineering, life science or related field.
• 7 to 8 years of experience in computer systems validation in the pharmaceutical industry, including at least 2 years managing/overseeing computer system validation projects.
• Subject matter expert in computer system validation, GAMP, Electronic Records/Electronic Signature regulations, and related health authority regulations and guidelines.
• Technical fluency in concepts and techniques related to software development and data management.
• Ability to plan and organize effectively across multiple projects.
• Ability to influence, collaborate, and communicate directly at various organizational levels.
• Proficiency in Microsoft Excel, Word, and Outlook.
• Strong analytical thinking, judgment, and understanding of quality philosophy.
• Flexibility, multi-tasking, attention to detail, organizational skills, and ability to prioritize.
• Ability to present technical information and results to stakeholders and gain cooperation across functional areas.

Pride Health/Russell Tobin & Associates offers eligible employees comprehensive healthcare coverage (medical, dental, vision), supplemental coverage options, a 401(k) plan, life & disability insurance, an employee assistance program, and other benefits including identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with preferred vendors.

Apply Today! If you are interested, please email your resume to  for immediate consideration.

• Seniority level:
  Mid-Senior level
• Employment type:
  
  Contract
• Job function:
  Science, Analyst, and Engineering
• Industries:
  Biotechnology Research and Pharmaceutical Manufacturing

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