Analytical CMC Quality Senior Manager (Contract) 667

The Senior Manager Quality Assurance (QA for QC) is an advanced technical resource in the principles and application of quality assurance and compliance. This role is responsible for the quality oversight of Quality Control and analytical development activities of Cell & Gene in scope of this role include release analytical testing stability testing and QA support for deviations and out of specification role will have QA oversight of technical analytical method validations and analytical transfer activities internally /CDMOs through the program life cycle management.

Key Duties & Responsibilities

Analytical Lifecycle Management:

• Serve as a Quality Assurance Subject Matter Expertfor inQC domain and drive culture of quality toassurecompliance with FDA EMA and internal SOPs.

• Lead QA review and approval of analytical developmentqualificationand validation as well as analytical technical transfer activities

Compliance & Investigations

• Ensuring proper root cause analysis (RCA) and Corrective and Preventive Actions (CAPA) for Out of Specification (OOS) and Out of Trend (OOT) results

• Perform/lead QA review and approval of QC associated documentation including deviation investigations OOS OOT and change control.

Digital & Artificial Intelligence

• Demonstrated understanding of digital quality systems data management automation and emerging AI technologies within regulatedGxPenvironments.

• Experienceleveragingdata analytics digital tools and AI-enabled solutions to improve quality oversight operational efficiency and decision-making.

Quality Management Systems (QMS)

• Support/lead QA risk management activities including mitigation plans and associated execution.

• Support development of Vertex quality systems and processes draft/revise SOPspoliciesand work instructions.

• Identifyfacilitate and/or lead continuous improvement efforts

• Ensure development of quality metrics at the contract organizations that support excellence in quality systems

Required Education Level

• Bachelors degree in a scientific or allied health field (or equivalent degree)

• Graduate degreepreferred

Required Experience

• 8 years of experience or the equivalent combination of education and experience in a regulated pharmaceutical environment.

Required Knowledge/Skills

• In-depth global regulatory agencyandtechnicalknowledge and experience across GXP QA and QC activities in cell therapies

• Broad understanding of regulatoryenvironmentincluding quality systemscomplianceandGMP regulations.

• Experiencewith platforms such as MES LIMSeQMS data visualization tools and advanced analytics is preferred.

• Prior experience working/running internal analytical lab and workingwith external Test labs.

• Experience in analytical method development

• Ability to lead improvement projects - experience with Root Cause Analysis data analytics and other Operational Excellence experience such as LEAN DMAIC SixSigma.

• Excellent communication skills and a proventrack recordInfluencing/building/promoting a culture of Quality and Excellence.

• Critical Thinking andProblem Solvingskills

Other Requirements