Senior Quality System Validation - Data integrity (Hybrid, Bothell, WA)

Senior Quality System Validation – Data integrity (Hybrid, Bothell, WA)

We are looking for a Quality Systems Manager for our client, a Global Biopharmaceutical Company. 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

This is a 40-hour per-week, 6-month contract, hybrid (~ 50% onsite) role in Bothell, WA. (The candidate must be able to work onsite approximately 50% of the time).

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

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 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.
• Collaborate with the Global Data Integrity Center of Excellence team to ensure adherence and alignment to Global DI policies and strategy as defined by the BMS Global DI program.
• Prepare and deliver communications to site leadership regarding risk, mitigations, data integrity metrics, and Global DI Program planning.
  
  

Requirements

• 8+ years of relevant work experience in pharmaceutical quality operations, quality assurance, quality systems, and IT compliance roles, with at least 3+ years in leadership.
• 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.
• BS or higher degree in an IT, engineering, scientific discipline, or other related field.
  
  

Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Senior Quality System Validation – Data integrity (Hybrid, Bothell, WA) role).

Compensation: $185 - $206.39/hr.

please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.