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Location

Cambridge, MA | United States

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Job description

Title: Senior Quality Assurance Consultant
Duration: 08 Months with possible extension
Location: Remote
I. Position Overview:
Previous successful project experience:
Cell Therapy Manufacturing Data Integrity Remediation Deviations:
Partner with key stakeholders to create a remediation plan that addresses the current AIQ (Analytical Instrument Qualification) work that has been identified through working with CT (Cell Therapies) CSQA.
Lead the transition from unstructured requests to a structured, prioritized, risk-based remediation project.
Scientific Data Management System Implementation in the Cloud:
Assess and initiate a 'fit for phase' quality approach for system implementation in multiple geographic areas, determining validation and qualification needs.
Align CSQA with a risk-based, phase-appropriate approach for project implementation in collaboration with the vendor
Medical Device Remediation Project:
Implement a real risk-based approach to reduce the effort required for remediation.
Guide the appropriate level of validation/qualification considering audit findings, patient safety, product quality, and technical feasibility.
Identify, track, and create a risk-based plan to address re-occurring issues (integrations, access, security, etc.) by cross referencing the issues, deviations, etc. for the past two years and using AI to uncover possible patterns in the data.
Mentoring Internal Quality Engineers and POD Teams:
Coach and develop an internal team of Two Quality Engineers, and additional IT staff, in risk-based approaches, regulatory compliance, and liaison strategies.

Qualifications:
Extensive experience in quality assurance and regulatory compliance in the pharmaceutical and medical device sectors.
Expertise in cell therapy manufacturing, cloud-based data management systems, and medical device remediation.
Proven ability to act as a mediator and communicator between technical teams and regulatory bodies.
Strong networking skills with a proven track record of applying industry best practices.
Excellent mentorship and coaching abilities.
Strong experience with GMP, GLP, GxP, and other relevant regulatory standards.
Strong experience with Lean and Agile Software Development Lifecycle Procedure
Provide expertise and guidance on additional projects and internal initiatives as required.
Be present in mock audits, support our team in actual audits and inspections to gain increased perspective i to train the QE and POD staff.
Understand the intricacies of the different client quality groups each POD interfaces with and work with these groups to provide a consistent approach to software quality.

Additional Requirements:
The consultant should have a robust network within the pharmaceutical industry to facilitate the exchange of best practices and innovative compliance strategies.
Flexibility to work in projects executed in different time zones USA (Boston), Europe (Vienna, Austria), and Japan
Experience with Jira.
Fluent in German
Employment Type: Contractor
Salary: $ 56.00 62.00 Per Hour

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