Sr. Manager, Data Integrity
The purpose of this spotlight call is to review the Sr. Manager, Data Integrity requisition. Please come prepared with questions to ask the manager.
PURPOSE AND SCOPE OF POSITION : This position reports into the Quality Assurance department and is responsible for assisting with the implementation and management of Client's GMP Data
Governance and Data Integrity program at the Bothell, WA manufacturing facility.
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.
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.
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