Provide direct Quality oversight of CMC-related activities (including validation and tech transfer) at CMOs/CTLs for pharmaceutical and medical nutrition clinical-stage programs and ensure compliance with cGMP, FDA, ICH and EMA regulations, guidelines, and industry standardsDevelop and implement risk-based Quality strategies including establishing and maintaining phase-appropriate quality systems; proactively identify and mitigate quality risksLiaise between the Qualified Person (QP) and internal/external partners to resolve queries and enable lot releaseLead and facilitate Quality Business Review (QBR) meetings between internal and external partnersPresent at Quality Review Boards (QRBs) as Quality Assurance SME, as necessaryNegotiate and maintain relevant and effective Quality Agreements at CMOs/CTLs and ensure adherence to requirements

Primary Quality lead on multiple clinical-stage products (early- and late-stage development), managing cGMP aspects relating to manufacture, testing, and release of drug substance, bulk drug products, packaged/labeled drug product, and clinical screening material at upstream and downstream CMOs, resulting in uninterrupted clinical trial supplyProvide quality and compliance oversight of quality systems, processes and records (internal and external) including, but not limited to: deviations/quality events, change controls, CAPAs, stability program, internal and external auditing, quality/technical agreements, annual product review, etc.Manage and perform lead investigator role on product complaints process (clinical and commercial)Primary reviewer of IND, IMPD, BLA and MAA regulatory filings and amendmentsVeeva Vault eQMS implementation support (UATs, workshops, trainings, legacy record migration)Lead and manage technology transfer process of clinical screening material upon CMO site closure and transferAuthor, revise, and implement departmental procedures ensuring compliance with applicable cGMPs, industry guidance and best practicesRepresent GMP QA and provide compliance guidance and input to cross-functional teams to achieve continuous quality improvement and effective quality controls

Provide Quality oversight and leadership for cGMP activities related to Aimmune products produced at CMOs/CTLsWork directly with operating entities (internal and CMOs/CTLs) to ensure clinical drug substance and drug products meet all required quality standards/specifications and are appropriately investigatedLead and perform QA audits/inspections (internal and external)Provide effective QA support for the manufacturing and disposition of clinical drug product lotsReview and approve CMO/CTL Specifications, Test Methods, Analytical Method Validation Protocols/Reports and Stability Protocols/ReportsWork with CMOs/CTLs to ensure CMOs/CTLs policies adhere to cGMPs; regulatory requirements of FDA, EMA and other regulatory agencies; and approved quality agreements. Monitor and provide corrective action recommendations to compliance issues and/or observations. Manage and coordinate process monitoring and continuous improvement initiatives per cGMP requirementsProvide support to ensure CMOs/CTLs achieve the appropriate levels of compliance and develop plans to ensure on-going performance is maintainedFacilitate resolution of quality issues in a timely manner. Coordinate communication with CMOs/CTLs and internal cross functional teams for quality issuesEstablish or revise assigned internal SOPs/Guidelines applicable to internal functions as well as outsourced functions to ensure compliance to cGMPEnsure compliance with Quality Systems such as change control, quality investigations, and CAPA resolutions

Establish and lead Quality oversight program of Site Operations including: MRO (Maintenance Repair Operations), FDT (Facilities Data Technology), Metrology, Reliability Engineering, SAP Master Data, Maintenance and Calibration Execution, Document Control, and Pest Control Program to maintain a state of inspection readinessApply advanced theory, technical principles, and expert judgment to address a broad range of compliance issuesManage, assess, and close Facilities, Equipment, and Utilities-related CAPAs, change records and complex deviations in TrackWiseProactively identify and recommend solutions to potential procedural, process and system gapsServe as Quality representative, troubleshoot and resolve compliance issues in interdepartmental and cross-functional teamsCreate and maintain Service Level Agreement between Quality and business partnersSupport Investigations/CAPA organization as trained InvestigatorCoordinate and facilitate weekly and ad hoc site QRB (Quality Review Board) meetings to review deviations, investigations, and critical complaints

Evaluate and close complex, non-investigational discrepanciesSupport and provide oversight of Manufacturing operations including real-time documentation and batch record review to ensure compliance with regulatory requirementsPerform Assessor and Evaluation activities including reviewing and closing completed evaluations as warranted in the Trackwise Discrepancy Management SystemRepresent QA at cross-functional meetings to troubleshoot and initiate the resolution of Quality-related issuesIdentify and recommend solutions to potential procedure, process and system gapsIndependently manage daily activities to meet standard lead timesCollaborate with internal and external departments on Lot Release commitmentsProvide support to various regulatory agency inspections/auditsReliability And Productivity Improvement Drive Team Member/Meeting Facilitator – represent Quality in a cross-functional forum focused on process improvements and mitigating equipment downtime to meet target product supply from Supply Planning

Sterile techniques and preparation of components (CIP/SIP of bulk vessels, aseptic sampling and autoclaving)Bulk processing (formulation of polysorbate, buffers, media, aliquots/dilutions, filtrations) with strict adherence to batch production records and a focus on detail and qualityProficient knowledge and operation of CIP/SIP skids, Freeze/Thaw skids, various HMIs and other bulk related systemsExperience using data acquisition software (SAP, DocLink, Labware LIMS)Consistently and properly adhere to all cGMPs, SOPs and safety guidelines to produce quality productsProvide administrative assistance in developing process diagrams, training matrices and manuals; facilitate staff meetings; perform monthly safety audits, escalate and resolve safety issuesShift 5S Coordinator - responsible for ensuring 5S walkthroughs are performed and shift scorecards are updatedProject Lead for push/pull tank project to automate transport of heavy vessels; eliminated all OSHA Recordables for tank movement injuries since 2012

Inspect commercially-marketed pharmaceutical products for sterility and cosmetic defects in the manufacturing processWork closely with management and Quality to accurately complete detail-oriented, process-related documentationPhotographed, documented, and archiving critical defects for vial defect gallery for reference and training purposes

Chair-side assisting during dental proceduresPreparing and sanitizing operatories between proceduresSterilizing instruments, maintaining dental supply inventoryOrganizing laboratory material and equipment, maintaining cleanlinessTraining prospective employees as needed