Quality Manager

Company: PQE Group
Location: San Francisco
Posted on: June 26, 2022

Job Description:

*NOT OPEN TO C2C CONTRACTS*We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998, with more than 1200 employees, 45+ nationalities and 27 subsidiaries all over the world (Europe, Asia and the Americas). Joining PQE means being a part of a multicultural and challenging company, with many local and international projects, and colleagues from all over the world.Due to constant growth, PQE is looking for a new Quality Manager to focus on Data Integrity (DI) for a GMP site. This will initially be a contract based 12 month assignment that will be worked on site near San Francisco, CA with a high possibility of extension.Responsibilities

• Support the QA compliance and validation groups by leading efforts to improve DI maturity level for process and technical systems.
• Create process maps, process data flow maps, data objects, risk assessments and final reports for multiple sites.
• Improve procedures for DI assessments and incorporate DI activities into the validation lifecycle.
• Support the implementation of a project plan to complete the assessments, improvement of impacted governing and validation documents, update to training modules, and systems mitigation/remediation prioritization for gaps control.
• Provide support in the event of internal, external and regulatory audits, including potential direct interaction with regulatory agency officials on queries related to data integrity.
• Participate in the gap analysis of the policies and procedures associated with data integrity, ensuring alignment of local Standard Operating Procedures (SOP) with corporate requirements.
• Gain deep understanding of data integrity incidents and ensure corrective and preventive actions are comprehensive and robust.
• Advocate to drive implementation of changes which will make compliance easier.
• Support the coordination of assignment of roles and responsibilities for the review, approval, and execution of plans necessary to meet data integrity standards. This includes coordination of the evaluation and, where required, remediation of new and existing electronic systems (IT, analytical, and production) to assure compliance with applicable requirements.Requirements
  • At least 7 years of experience with data integrity and quality management systems.
  • Bachelor's degree in science, business, or related field.
  • Agile enough to move between being tactical and strategic.
  • Knowledge of Part 11, Annex 11, and other relevant regulatory requirements.
  • Willingness to go on the shop floor for site walks.
  • Experience with QC lab operations and manufacturing operations, including data flow and DI.
  • Six-Sigma Green Belt and/or Black Belt certification is a major plus.Location: San Francisco, CAOur collaborators are engaged, developed, challenged and well-rewarded for performance.We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.

Keywords: PQE Group, San Francisco , Quality Manager, Executive , San Francisco, California