This position reports to the Quality Assurance department and is responsible for assisting with the implementation and management of the GMP Data Governance and Data Integrity program at the Bothell, WA manufacturing facility.

Experience:

• Eight (8) or more years of relevant work experience in pharmaceutical quality operations, quality assurance, quality systems, and/or IT compliance roles 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.

Key Knowledge, Skills, and Abilities:

• Demonstrated excellence in written and verbal communication.
• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
• Demonstrated ability to work effectively with US FDA, EU and other regulatory agencies. Substantial knowledge of QSR, GMP, FDA, GAMP, ICH, ISO and other applicable standards.
• Demonstrated expertise in Data Integrity principles and GxP knowledge with ability to recognize Data Integrity risks and develop mitigation plans.
• Demonstrated record with driving continuous improvement and fostering a compliant operational excellence culture.
• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a leader of team(s) to engage and influence team members in a matrixed environment.
• Demonstrated experience utilizing Risk Management tools (e.g. FMEA, FTA tools) to understand and reduce overall risks through effective CAPA planning and implementation.
• Experience performing site and functional audits and walk-throughs.

DUTIES AND RESPONSIBILITIES:

• Serve as the site DI subject matter expert (SME) and promote/train/coach site staff on ALCOA principles and associated worldwide regulations.
• Ensure site meets the expectations of the Global BMS Data Integrity program, including but not limited to the annual DI Master Plan, DI training curriculum ownership, and launching DI related initiatives to promote the DI culture within the organization.
• 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.
• Periodically report the Data Integrity metrics of the site through the Site Quality Management Review and to the Global DI COE.