Role: Sr. Manager, Data Integrity

Location: Bothell, WA

Contract: 12 Months

Duties and responsibilities:

• Key responsibilities Serve as the site DI subject matter expert (SME) and promote/train/coach site staff on ALCOA principles and associated worldwide regulations.
• Ensure the validation, implementation and change management of e-systems used across the site operations are conducted in compliance with applicable Data Integrity related regulatory requirements (FDA, EMA, etc)
• Responsible for ensuring systems at the Bothell site comply with data life cycle requirements from initial data creation/recording to archival and decommissioning. This includes, but is not limited to, data management (e.g., data creation, data processing, review, reporting), data security, data traceability process mapping, data backup/restore, electronic signature/electronic record linking and data audit trails.
• Responsible for leading, reviewing, and approving data integrity assessments for GxP systems and processes including, but not limited to, manufacturing and laboratory systems/processes to ensure compliance with regulatory requirements and company established requirements for data integrity.
• Effectively partner with cross-functional stakeholders to ensure both systems and processes are DI compliant through governance and risk control, and drive mitigation/remediation actions when DI gaps are identified.

Required competencies: knowledge, skills, and abilities:

• Education: BS or higher degree in an IT, engineering, scientific discipline, or other related field.
• Experience:
• Eight (8) or more years of relevant work experience in pharmaceutical quality operations, quality assurance, quality systems, and/or IT compliance role with at least 3 years in a leadership position.
• Expertise with 21 CFR Part 11, EU Annex 11 and GAMP standards for DI and validation of automated systems is required.
• Experience with QA oversight of e-systems for GMP operations is required.