Piper Companies is seeking a Senior Manager of Data Integrity to join a client that discovers, develops and delivers innovative medicines that help patients prevail over serious diseases. This is a very high level, 6 month contract-to-hire, hybrid role located out of Bothell, Washington.

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

Responsibilities:

• Responsible for being the Data Integrity subject matter expert (SME) and promoting, training, coaching staff on ALCOA+ principles and global regulations.
• Ensure validation, implementation and change management of e-systems are conducted in compliance with Data Integrity regulatory requirements (FDA, EMA, etc).
• 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.
• Leading data integrity assessments for GxP systems.

Requirements:

• Eight (8) or more years of experience in pharmaceutical quality operations, quality assurance, quality systems, and/or IT compliance.
• 3+ years in a leadership position.
• Expertise with 21 CFR Part 11, EU Annex 11 and GAMP standards for DI required.
• Experience with QA oversight of e-systems for GMP operations is required.
• Ability to work effectively with US FDA, EU and other regulatory agencies. Knowledge of QSR, GMP, FDA, GAMP, ICH, ISO and other applicable standards.
• Demonstrated expertise GxP knowledge.
• Proven leadership ability.
• Experience utilizing Risk Management tools (e.g. FMEA, FTA tools).
• BS or higher degree in an IT, engineering, scientific discipline, or other related field.

Compensation / Benefits:

• $175 / hour - $185 / hour.
• 6 months contract-to-hire.
• Hybrid role, 50/50, out of Bothell, WA.