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It Risk And Compliance Manager

Company

FibroGen, Inc.
Address , Remote
Employment type FULL_TIME
Salary $160,800 - $184,000 a year
Expires 2023-06-25
Posted at 1 year ago
Job Description
  • Manage the Software Development Lifecycle and Change Control processes (SDLC), using standard procedures for documenting business-lead, IT projects. The objective is prompt and efficient handling of changes to systems, reducing impact on the business and maintaining compliance with industry regulations.
  • Participate in vendor audit and identify deficiencies to ensure validation deliverables are in compliance with site and corporate policies and procedures.
  • Ensure GxP document deliverables are in compliance with site and corporate policies and procedures following risk-based lifecycle approach from URS development through system retirements.
  • Work closely with IT Compliance & Risk team, to develop and implement internal control and procedures that will enable the business to stay compliant with regulated requirements including but not limited to GxP, SOX.
  • Manage internal compliance requirements, including training, documentation management, change management, and non-GxP CAPA system.
  • Perform IT quarterly internal testing to ensure all processes and controls are followed and remediate deficiency if any,
  • Work with project teams to select methods and techniques for obtaining desirable solutions for each GxP project and work with Quality Assurance to ensure compliance with regulations.
  • Maintain the controlled GxP computerized system inventory, identify deficiencies in the validation status and prioritize remedial actions based on risk.
  • Oversee and/or assists in the development of validation deliverables including Validation Plans, Test Plans/Protocols/Scripts, Specifications and Design Documents, Compliance Assessments, Risk Assessments, Installation Qualification, System and User Acceptance Testing, Data Migration Plans, Traceability Matrices, Validation Reports, Supplier Assessments, etc.
  • Assist and support for internal auditors and external auditors during scheduled IT audits.
  • Lead process improvement efforts of computerized system policies, procedures and computerized system validation processes.
  • Work closely with business stakeholders, technical support groups including vendors, and Quality Assurance to thoroughly investigate validation discrepancies, and drive remediation for system validation.
  • Provide technical expertise to define approaches and execution of system validation activities in accordance with GxP, CFR Part 11, and other applicable regulations or procedures.

Job Requirements:
  • Excellent teamwork and collaboration skills.
  • Ability to work effectively with minimal supervision.
  • Detail oriented with the ability to identify gaps and propose solutions.
  • Must demonstrate working knowledge of business risks and internal controls and procedures, including Internal Audit and compliance
  • Excellent interpersonal, written, and verbal communication skills required.
  • Understanding of the requirements of computer system validation in a regulated pharmaceutical environment (part 11 compliance and risk-based approach).
  • Strong planning, organization, and communication skills.
  • Strong technical understanding of computer system design, architecture, implementation, integration, and IT infrastructure.
  • Ability to communicate effectively within cross-functional teams.
  • Ability to communicate complex topics in simple terms to any audience.
  • Bachelor's degree from an accredited institution in the field of computer science, science, or engineering.
  • Experience working in a GxP environment.
  • Knowledge of GxP, FDA, and EU regulations including 21 CFR Part 11, Risk-driven System Development Life Cycle (SDLC) methodologies, and change management processes.
  • Strong technical background in computer systems, such as architecture, design, implementation, integration, or support.
  • Excellent planning and project management skills.
  • At least seven (7) years of experience in computer system validation with increasing responsibilities (five (5) years of recent experience in a pharmaceutical manufacturing environment).
SALARY RANGE
$160,800.00-$184,000.00
FibroGen is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender identity/expression, creed, national origin/ancestry, age, alienage or citizenship, status, age, sex, sexual orientation, marital or domestic/civil partnership status, disability, veteran status, genetic information, or any other basis protected by law.FibroGen will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.
At FibroGen we continue to strive to build a diverse and equitable workplace; we share the typical minimum and maximum salary ranges on all job postings. For annual base pay, we typically set standard ranges for positions based on function and level benchmarks. Further, we establish fixed annual bonus targets, expressed at a % of annual base pay, based on level in the organization. Bonus awards are determined based on assessment of individual and corporate goal achievement. All compensation offers of employment are determined by multiple factors including a candidate’s relevant qualifications, work experience, skills, and other factors and may vary from the amounts listed above.
Notice to Recruiters and Search Firms
FibroGen does not accept unsolicited resumes or communications. Contact with a hiring manager or submission or presentation of candidates by recruiters or placement agencies without a current signed agreement with FibroGen will not constitute, in any form, a financial obligation or agreement for recruitment services or placement support or consulting fees.
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