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Sr Manager, Quality Systems Validation

Boston, MA

Posted: 06/02/2020 Employment Type: Contract Job Category: Clinical: Quality Job Number: 2597

Job Description


Our client is looking for the right individual with the technical and leadership capabilities to support their Quality Systems Validation efforts. Reporting to the Director of Quality Systems Validation, the role will be hands-on and leverage collaboration, communication and influencing skills in executing the client' s Computerized System Lifecycle management (CSLC) process.

This person will be assigned responsibilities that support the lifecycle of the GxP Computerized Systems and is expected to provide subject matter expertise and problem solving as well as guidance on requirements as defined in the client' s Quality System.

Responsibilities:
  • Provide computer validation support as the Quality Systems Validation role for computer system assessments, validation and change control, and provide effective Quality support at all applicable points of the client' s Computerized System Lifecycle (CSLC)
  • Perform timely and effective QA review of validation documentation such as Validation Plans, Traceability Matrices, testing deliverables, SOPs, and data migration plans
  • Provide timely updates on IT validation projects and deliverables to Quality Systems management
  • Work in collaboration with Quality Systems Validation management, Business Owners and IT Owners to execute or support Periodic Reviews of Computerized Systems.
  • Support and foster an environment conducive to innovation, high productivity, and high quality

Requirements/Qualifications:
  • Bachelor' s degree with at least 8 years’ experience in computerized system validation projects
  • Proven experience in managing the Quality aspect of validation projects
  • Authoring clear and effective validation deliverables and SOPs
  • Thoroughly  familiar with ALCOA+ principals
  • In-depth knowledge of quality systems principles (e.g. Change Management, Deviations / CAPA) and applications to the pharmaceutical industry
  • Familiarity with virtualization and cloud models in the pharmaceutical industry
  • Effective communication and interpersonal skills to influence and resolve conflict
  • Critical / strategic thinker with ability to identify and clarify complex problems and constructively provide potential solutions
  • Knowledge of GxPs, ICH, and GAMP Guidance

Meet Your Recruiter

Heather Ward
Clinical Recruiter

Heather is driven by a passion for continuous growth and thrives by engaging with others. She brings an empathetic nature, customer-focused approach, and six years of recruiting experience to her role at The Steely Group.

This lifelong learner was first drawn to recruiting for the opportunity to impact and influence people’s lives. “Supporting my candidates and helping them achieve their professional goals is important to me,” she says. “It’s very rewarding to know that I’ve contributed to their success.”

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