Data Consultant

5 days ago

Bothell, United States Areti Group Full time

Currently I am looking to speak with Lead Data Consultants for a long term contract.

Position: Senior Lead Data Integrity Consultant

Location: Bothell, WA

Visa Must be Green Card holder or American Citizen

Duration: 12+ months

Onsite Requirement: 50%

Job Overview: This role reports to the Quality Assurance department and is responsible for supporting the implementation and management of the GMP Data Governance and Data Integrity program at the Bothell, WA manufacturing facility.

Experience Requirements:

  • Minimum of eight (8) years of relevant experience in pharmaceutical quality operations, quality assurance, quality systems, and/or IT compliance, with at least 3+ years in a leadership role.
  • Expertise in 21 CFR Part 11, EU Annex 11, and GAMP standards for Data Integrity (DI) and validation of automated systems.
  • Experience overseeing QA for e-systems in GMP operations.

Key Knowledge, Skills, and Abilities:

  • Proven excellence in written and verbal communication.
  • Strong ability to work cross-functionally and maintain solid business partner relationships.
  • Effective collaboration with regulatory agencies like US FDA and EU authorities.
  • Deep understanding of QSR, GMP, FDA, GAMP, ICH, ISO, and other relevant standards.
  • Expertise in Data Integrity principles and GxP knowledge, with the capability to identify and mitigate Data Integrity risks.
  • Proven track record of driving continuous improvement and fostering a culture of compliant operational excellence.
  • Leadership skills to make difficult decisions logically and rationally, and the ability to lead teams in a matrixed environment.
  • Experience with Risk Management tools (e.g., FMEA, FTA) to understand and reduce risks through effective CAPA planning and implementation.
  • Experience conducting site and functional audits and walk-throughs.

Duties and Responsibilities:

  • Act as the site Data Integrity (DI) subject matter expert (SME), promoting, training, and coaching staff on ALCOA+ principles and related regulations.
  • Ensure the site aligns with the Global Data Integrity program, including the annual DI Master Plan, DI training curriculum ownership, and launching DI initiatives to foster a DI culture within the organization.
  • Oversee the validation, implementation, and change management of e-systems across site operations to ensure compliance with relevant Data Integrity regulatory requirements (FDA, EMA, etc.).
  • Ensure systems at the Bothell site comply with data life cycle requirements from initial data creation to archival and decommissioning, covering data management, data security, traceability, backup/restore, electronic signature/record linking, and data audit trails.
  • Lead, review, and approve data integrity assessments for GxP systems and processes, including manufacturing and laboratory systems, to ensure compliance with regulatory and company data integrity requirements.
  • Collaborate with cross-functional stakeholders to ensure systems and processes are DI compliant through governance and risk control, and drive mitigation/remediation actions when DI gaps are identified.
  • Periodically report Data Integrity metrics through the Site Quality Management Review and to the Global DI Centre of Excellence.

Please reach out if you need any further information

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