Jonathan Briggs Email & Phone Number

Portsmouth, NH, US

Boston, Massachusetts, US

Global responsibility for Quality including GxP compliance, inspection management, and providing QA oversight of operations associated with commercial and clinical product manufacturing, testing, distribution, clinical studies, pharmacovigilance, and non-clinical studies.

Providing expert guidance and strategy to biopharmaceutical and medical device companies, including quality operations, quality leadership, inspection management, and remediation in all areas of GxP quality and compliance.

Head of Quality for clinical stage cell-therapy development company in Cambridge, Massachusetts, with global responsibility for QC/QA oversight of all GxP operations including GMP manufacturing, clinical studies, and vendor management.Responsible for Quality Assurance, Compliance and Quality Systems functions, including regulatory inspections, supplier.

Newton, MA, US

Site Head of Quality responsible for Quality Assurance at the Boulder biopharmaceutical manufacturing facility. Responsible for hosting regulatory inspections Quality Operations, QA oversight of bulk drug substance, raw material release, equipment/facility, process and computer system validation functions, deviation management, oversight of manufacturing.

Basel, CH

Head of QA for US Operations with responsibility for GxP compliance, hosting regulatory inspections, and providing QA oversight of operations associated with product distribution, clinical studies, pharmacovigilance, and non-clinical studies. Responsibilities include vendor management, change control, Quality agreements, training and managing QA compliance.

Global responsibility for Quality Assurance Compliance and Quality Systems functions, including regulatory inspections, supplier quality, vendor management, training, audits and managing QA compliance for all GxP operations at CMOs, CROs and test labs in the production and testing of commercial and clinical products.Responsible for Supplier Quality, GxP.

Responsible for QA and Compliance at Heron Therapeutics. Focused activities for successful PAI, transfer to a commercial operation, and ongoing product development for clinical trial materials and NDA filing. Our company was renamed on January 13, 2014 from A.P. Pharma, Inc. to Heron Therapeutics.

Basel, CH

Implemented and led Deviation Review Board.Provided QA guidance in closure of deviations, CAPAs, and change controls.Assisted with regulatory inspection preparation activities.Provided QA Person-In-The-Plant oversight of manufacturing operations.

Basel, CH

Responsible for Quality Assurance at Lonza Biologics at the Portsmouth manufacturing facility.

Boston, Massachusetts, US

Responsible for Quality Assurance at Alexion's Rhode Island manufacturing facility.

Responsible for all Quality Assurance and Quality Control operations for a global pharmaceutical company with multiple monoclonal antibody products in international clinical trials.

Directed the operations of Quality Assurance department responsible for all QA functions, including drug substance release, document control, change control, deviations, investigations, CAPA’s, batch record review, supplier qualification, and the audit program. Provided quality assurance oversight of manufacturing operations for recombinant protein bulk.

Managed the operations of Quality Assurance department responsible for all QA functions, including drug substance release, drug product release, GCP operations, GLP operations, document control, change control, deviations, investigations, CAPA’s, batch record review, and the audit program.

US

Led Quality Assurance function, managed the day-to-day operations of Quality Assurance department, including drug substance release, drug product release, document control, change control, validation, deviations, investigations, CAPA’s, batch record review, GLP report review, and the internal and external audit programs. Provided quality assurance.

South San Francisco, California, US

Managed the day-to-day functions of Clinical Quality Systems group responsible for change control, deviations, investigations, and CAPA’s resulting in GMP compliant operations meeting corporate deviation closure on time metric for 90% of time and CAPA closure on time metric for 90% of duration.Ensured quality resources were applied efficiently and lot.

South San Francisco, California, US

New Brunswick, NJ, US

Provided QA guidance to and established requirements for aseptic implant project team for cGMP manufacturing of Clinical Trial Materials resulting in successful media fills for new filling line. Approved equipment qualification protocols/reports and operating/PM/Cal SOP’s for 17 equipment systems for GMP manufacturing in support of successful media fills..

Emeryville, California, US

Supervised QA review of Betaseron batch records for commercial and clinical production. Completed QA evaluations and led investigations into Manufacturing and QC non-conformances. Supervised QA review of two significant contract manufacturing projects for Emeryville manufacturing resulting in successful production of nine bulk lots for clinical trials..

Provided Quality Assurance guidance and support to six clinical development project teams including insulin and alpha-1 proteinase inhibitor. Managed and coordinated cleaning validation program activities for GMP manufacturing equipment. Authored, reviewed and approved drug analytical method and cleaning validation protocols and reports for QA. Hosted and.

Carried out and managed numerous insulin stability studies and solubility studies in support of Phase I and Phase II clinical studies resulting in final insulin formulation for marketed product Exubera.

Designed and developed liquid formulations for recombinant insulin-like growth factor I (rhIGF-I), recombinant human insulin-like growth factor binding protein 3 (rhIGFBP-3), and recombinant human insulin-like growth factor complex (rhIGF-1/rhIGFBP-3). Designed the current rhIGF-1/rhIGFBP-3 parenteral formulation vial configuration for toxicology, Phase I.