Director, Computer System Lifecycle Management

11 - 15 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 09/21/17
Aliso Viejo, CA
11 - 15 years experience
Biotech/Pharma
Salary depends on experience
Posted on 09/21/17

POSITION SUMMARY
The Quality team supports Avanir throughout the product development and commercial life cycle by interacting with regulatory agencies, facilitating regulatory activities, preparing regulatory documentation, and coordinating company-wide interactions. This is accomplished with a thorough understanding and knowledge of quality requirements to support and ensure that Avanir operates within and in compliance with applicable regulations.

The incumbent will be responsible for workingcloselywiththeExecutive Director, Quality and other functions with AVANIR as well as externally with Vendors that supply GxP Computer Systems products and services inthe development, management, and execution of a successful and effective Computer Systems Life Cycle Risk Assessment and Validation Program including a process where electronic generated GxP data are audited for data integrity and part 11 compliance requirements.

ESSENTIAL JOB FUNCTIONS

  • Provides a quality oversight to ensure global compliance with government regulations, and applicable regulations with Computer Systems Life Cycle Management and Validation, and managing the Data Integrity following FDA Data Integrity Guidance document requirements.
  • Interact with government agencies during GMP inspection as SME in CS Validation and defend CS systems successfully.
  • Develop, improve, implement, execute, and manage an effective computer systems risk assessment and life cycle validation management processes, including assessing and auditing AVANIR GxP data generated from Validated IT solutions for data integrity and Part 11 Compliance. This applies both internally at various GxP functions within AVANIR as well as working and managing with external Suppliers to ensure that any Computer Systems products and services meet Part 11 and regulatory requirements for CS Validation.
  • Provide ongoing training on CS Validation requirements
  • Participate in internal and external Vendor audits to assess the compliance with Computer Systems Validation, Part 11 Compliance, validity and data integrity requirements.

QUALIFICATIONS

  • 10+ years of experience in pharmaceutical industry with at least 7 years of Quality Systems specially with successful implementation of Computer Systems Validation.
  • Strong working knowledge of cGMPs, Part 11 Compliance, and Data Integrity Guidance Document.
  • Must have excellent computer, written and verbal communication skills.
  • Must be able to effectively collaborate with peers and comfortable working in a matrixed team.
  • Must have experience interacting with global agencies and acted as SME.
  • Must be solutions oriented and pragmatic
  • Excellent project management skills are a must
  • Must have internal and external GxP auditing experience as CS, as AVANIR Subject Matter Expert.

R1433

  • POSITION SUMMARY
    The Quality team supports Avanir throughout the product development and commercial life cycle by interacting with regulatory agencies, facilitating regulatory activities, preparing regulatory documentation, and coordinating company-wide interactions. This is accomplished with a thorough understanding and knowledge of quality requirements to support and ensure that Avanir operates within and in compliance with applicable regulations.

    The incumbent will be responsible for working closely with the Executive Director, Quality and other functions with AVANIR as well as externally with Vendors that supply GxP Computer Systems products and services in the development, management, and execution of a successful and effective Computer Systems Life Cycle Risk Assessment and Validation Program including a process where electronic generated GxP data are audited for data integrity and part 11 compliance requirements.

    ESSENTIAL JOB FUNCTIONS

    • Provides a quality oversight to ensure global compliance with government regulations, and applicable regulations with Computer Systems Life Cycle Management and Validation, and managing the Data Integrity following FDA Data Integrity Guidance document requirements.
    • Interact with government agencies during GMP inspection as SME in CS Validation and defend CS systems successfully.
    • Develop, improve, implement, execute, and manage an effective computer systems risk assessment and life cycle validation management processes, including assessing and auditing AVANIR GxP data generated from Validated IT solutions for data integrity and Part 11 Compliance. This applies both internally at various GxP functions within AVANIR as well as working and managing with external Suppliers to ensure that any Computer Systems products and services meet Part 11 and regulatory requirements for CS Validation.
    • Provide ongoing training on CS Validation requirements
    • Participate in internal and external Vendor audits to assess the compliance with Computer Systems Validation, Part 11 Compliance, validity and data integrity requirements.

    QUALIFICATIONS

    • 10+ years of experience in pharmaceutical industry with at least 7 years of Quality Systems specially with successful implementation of Computer Systems Validation.
    • Strong working knowledge of cGMPs, Part 11 Compliance, and Data Integrity Guidance Document.
    • Must have excellent computer, written and verbal communication skills.
    • Must be able to effectively collaborate with peers and comfortable working in a matrixed team.
    • Must have experience interacting with global agencies and acted as SME.
    • Must be solutions oriented and pragmatic
    • Excellent project management skills are a must
    • Must have internal and external GxP auditing experience as CS, as AVANIR Subject Matter Expert.
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