Provided oversight of the Quality Team > 25 team members to include QA Document Control, QA Operations, QA Client Management, QA Validation, GMP Training, and QA Compliance. Evaluate and implement quality systems from paper-based processes. Ensured timely lot release of IND drug products to support clinical program timelines.• Drove continuous process improvement using quality metrics for deviation closure (40% reduction average closure) and lot release generating revenues of $25 million.• Facilitated client audits, communications, and deliverables to maintain high client satisfaction and compliance with cGMPs.• Provided responses to the FDA for quality questions associated with the manufacture of gene therapy investigational drug product Zamtocabtagene clinical trial NCT04792489 with no additional follow-up required.

QA representative on CMC teams focused on mAb production, testing, and labeling activities. Led QA operational oversight of mAb CMO/CTL and suppliers.• Reviewed and approved mAb Master Batch Record (MBR) in compliance with GMP regulations, regulatory filings, and quality agreements.• Evaluated and approved executed batch records, raw analytical data, stability protocols, reports, data, and other GMP documents to enable drug substance and final drug product release for critical Covid19 antibody Sotrovimab.• Examined and approved change controls, deviations, and investigations at CMOs/CTLs.

Provided leadership and management in Quality Operations to support Clinical Manufacturing both in-house and at CMOs for Autologous Cell Therapy Products. Participated in IND amendment by reviewing several CMC sections for Cell Therapy Products. Provided training and guidance on QA topics to foster a quality culture and quality mindset.• Authored, reviewed, and approved QA SOPs to support PACT Pharma Quality System (Quality Agreement, Training, Deviation, CAPA Management Program, and Document Review for Clinical Manufacturing).

Prepared and approved quality agreements with CMOs. Participated in IND submission by preparing and reviewing several CMC sections for Cell Therapy Products resulting in IND approval for Phase 1 Clinical Study NCT03970382.• Performed audits of Contract Manufacturing Organizations (CMOs) to support supplier quality programs.

Provide leadership and management in Quality Operations to support Manufacturing activities in Drug Substance Plant 1 to ensure timely delivery with high quality product. Communicate and interact with multiple stakeholders for example Business Units (Plant 1, Plant 2 and Aseptic Filling), Functional teams (Manufacturing, Materials Management, Quality Control, Validation, Facilities, Manufacturing Science & Technology, Business Development, Procurement, Human Resources and Project Management) and Clients to support scheduling demands. Delegate activities and provide timely updates on Quality Operations (MBR review, On-the-Floor walk-throughs, Validation, Quality Metrics and Quality Control activities) to senior management.

Responsible for the implementation, maintenance and adherence to quality systems to ensure high quality deliverables for clinical and commercial use.Lead and managed Non-Conformance Investigations, Change Control and Corrective and Preventative Actions.Participated in a successful Pre-Approval Inspection with regulatory agency (FDA) for Pandemic Flu Vaccine project resulting in licensure Participated in a successful Technical Transfer for Flu Vaccine program from California USA to Liverpool UK.

Participated in the design and implementation of quality systems for Cell Therapy project.Quality Assurance Technical Transfer (QATT) representative from clinical to commercial for several late stage development projects utilizing drug delivery system – OROS oral delivery.Quality on the Floor for line clearance activities and manufacturing partnership program.Participated in the design and implementation of an aseptic manufacturing area for drug delivery system – MACROFLUX transdermal.Participated in successful health authority inspections by both EMEA and FDA for PAI 4mg Jurnista and CR-Vicodin®.

Initiated, investigated and resolved non-conformances in cell culture manufacturing within 30 days.Revised standard operating procedures and master batch records in Cell Culture Manufacturing to address CAPAs.Implemented process excellence concepts of lean thinking to improve batch record management. Provided GMP consultations and training to business partners related to CAPAs and equipment validation.

Participated in a successful PAI for a $200 million facility.Participated in the implementation of an enterprise resource planning system (SAP) in a cGMP manufacturing environment.Established systems for documentation management of batch records, standard operating procedures (SOP) and QC test results.Achieved > 95% accuracy for inventory reconciliation.Supervised and generated goals and expectations for a team of 12 employees.

Attained > 90% success for cell culture operations attempted.Supervised and generated goals and expectations for a team of 4 technicians.Investigated and completed Manufacturing variance reports.Reviewed batch records daily for correct GMP documentation to minimize delays in Quality Assurance lot release.Investigated process anomalies related to dO2 control, low titer yields, clogged media filters and implemented improvements to optimize the process.Participated in a successful PAI with the Food and Drug Administration.

Managed operations in CCP to support marketed products and cell culture process development runs.Supervised and generated goals and expectations for a team of 10-14 technicians.Participated in a successful FDA inspection for multi-product facility.

Performed a variety of manufacturing operations; including media preparation, cell culture, bacterial fermentation and purification.