Analytical CMC Quality Senior Manager (Contract) 667

Job Description

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 programs.Activities in scope of this role include release analytical testing, stability testing, and QA support for deviations and out of specification investigations.The 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 development,qualificationand 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 SOPs,policiesand work instructions.

• Identify,facilitate, and/or lead continuous improvement efforts

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

Required Education Level

• Bachelor's 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 systems,complianceandGMP regulations.

• Experiencewith platforms such as MES, LIMS,eQMS, 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

Up to 5% travel

Pay Range

$90-$105/hr

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

No C2C or Third-Party Vendors