QA Lead Technical Operations

Job Description/ Responsibilities:Provides Quality Assurance (QA) support to Devens Site and reporting Manager through quality review and approval of Investigations and Corrective Actions.Decision-making of non-conformance through a deep understanding of Quality Systems Regulatory expectationsReviews and approves Quality, Quality Control, Validation and Automation documentsReview and approve Standard Operating Procedures(SOPs).Review and approval of Validation documentation such as risk assessments, protocols, and test scripts and summary reports.Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements.Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation.Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working environmentAble to interpret complicated data and make sound decisions, Independently This position will regularly interact with:Reporting Manager Sometimes will interact with the departments listed below:Quality ControlManufacturing OperationsManufacturing EngineeringManufacturing Science and Technology (MS&T)ValidationSite EngineeringDigital Plant Education, Experience, and Qualifications:Knowledge of science is generally attained through studies resulting in a B.S; in Biological science, Engineering,biochemistry, or related discipline, or its equivalent is preferred.Advanced Level of relevant experience in a GMP,GCP, or GXP with at least 8 years focused on productquality. Preferred Active member of ASQ or ISPE.Prior experience of QC equipment Qualification and some project management experienceKnowledge of biotech, bulk drug substance or finished product manufacturing, and medical device analytical testing ishighly desirable.