myGwork - LGBTQ+ Business Community · 3 days ago

Senior Manager, Quality Validation and Engineering

Boston, MA

Full-time

Onsite

Senior Level

7+ years exp

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Responsibilities

Responsible for providing quality oversight and support ensuring compliance standards and practices are maintained for validation activities, facilities operations, and facility control programs.

Serve as Quality Lead for multiple projects, foster cross-departmental collaboration, and provide compliance oversight for various quality systems and associated records.

Lead and drive accountability of a team of quality professionals, support internal audits and regulatory inspections, and participate in work process optimization and continuous improvements.

Qualification

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QA SupportProject ManagementTechnical ExpertiseSystem ValidationCGMPCGxPCFR 21ICH Q7ICH Q8ICH Q9Manufacturing Equipment QualificationLaboratory Instrument QualificationFacility System QualificationUtility System QualificationEvent InvestigationsRoot Cause AnalysisCAPAGMP ManufacturingCell TherapyDrug Product DevelopmentCMC RegulatoryChange ControlsProblem-SolvingCommunicationInfluenceTeamworkSystem AutomationNetwork-Based ApplicationsOracleVeeva

Required

Demonstrated aptitude for facilitating group or project team endeavors and building team unity

Demonstrated ability to effectively communicate and influence the outcomes of the decision-making process

Demonstrated ability to work independently to provide QA support for large, multifaceted projects

Demonstrated success independently leading cross-functional teams

Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q8, Q9 and applicable regulations and industry standard procedures.

Experience with qualification of manufacturing equipment, laboratory instrument, and facility and utility system in a cGMP setting.

Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA

Experience providing QA support and oversight of GMP manufacturing operation

Experience with cell therapy drug product development and manufacturing with proficient knowledge of the following in a pharmaceutical setting: cGMP’s and associated CMC regulatory considerations

Experience with equipment, facilities and utility system qualifications activities in a cGMP setting, including quality management of change controls

Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA

Advanced degree in scientific and/or engineering disciplines with minimally 3 years of relevant work experience, or B.S in scientific or engineering field (or equivalent degree) and 7+years of relevant work experience