Greater Boston
Provides QA & QC GxP services to the Life Sciences / Bio Pharmaceutical Industries that ensures a robust audit ready GxP compliant drug product package. Ensuring survival of regulatory scrutiny and ultimate approval of product. Key expertise in GLP, GMP and GCP implementation and management. Create and implement phase appropriate QMS program. Ensures part 11 compliant software validation. Key expertise with EU QP declaration and global clinical trial approval. Aid with development of phase 3 and commercial design for product manufacturing and analytical programs. •Global Development and Commercial experience with biologics and small molecule. Global quality assurance expert in GxP (GMP/GCP/GLP), EU Directives, ICH quality compliance; •Experienced in Global auditing, biological and small molecules •Ensures document traceability and process/site PAI readiness. •Experience with management of contract manufacturing operations ( CMO ) and commercial site approval. •Expertise for on time release of API, drug substance and drug product concurrent with meeting aggressive timelines and clinical trial supply needs. •In depth understanding of process development, from pre-clinical through phase 3 and approval. •Participate with post marketing (Phase 4) clinical studies. •Recent responsibilities for site and system GMP validation, Deviations, Investigations, CAPA and Change Control. •Assures compliance and implementation of product quality systems. •Oversee process and closure of deviations and investigations within required time frames. •Assures an effective CAPA system and Management Review of follow-up actions. Supervises the Material Review Board process assuring thorough investigations, reports, and decisions are properly documented •Experience and responsible for labeling, packaging, and clinical site management for clinical trial supply.
L. Reed Global QA, Inc continues to serve the Life Science community with GxP support of development manufacturing and analytical processes and management of clinical phase material. We provide both QA & QC services.
Recent Successes: Retained to work with a phase I-II gene therapy AAV CMO as QA Consultant to assess, plan and implement necessary systems to create a robust phase 3 – commercial GMP facility. GCP QA support for Clinical Trial Management Quality Assurance support from November 2015 – November 2018 for Potenza Therapeutics, successfully stage quality programs for partner buy out. Completed December 2018. Work as QA Support for Gene Therapy AAV product to treat CHM, an inherited retinal disease caused by mutations in the CHM gene on the X chromosome. Client purchased by Biogen 2019. • Head of Quality (GxP) for Cambridge small molecule start up creating and implementing Quality Systems. • Work with a consultant-based CMC team to manage client development efforts providing QA support to create, implement and direct compliance programs that ensure FDA PAI GMP audit readiness state for oncology product produced in EU and USA working within CMO locations. • In behalf of client, participate in a CMC third party (Shanghai, China, USA) cross functional group responsible for assistance with launch of commercial product providing QA GMP over-sight of manufacturing compliance and disposition of commercial product. • Participate and complete serialization of commercial product. • Perform Client audits in USA, EU and China CMO and CTL sites to ensure both GMP (Part 210 and 211) and GLP (Part 58) compliance. • QA Lead for due diligence assessment of manufacturing facilities located in South America. • Create client-based document repository and document change control within Share-point system. Ensure client documents are appropriately stored, secure and manage change control.
Head of Quality Assurance,
Work with LOPC CMC team to support client development programs and client commercial product management and disposition.
Senior QA Consultant within the Bio Pharmaceutical industry. •Create and implement a Quality Assurance Consultant team to meet client industry GxP and CMC requirements. Work with LBG members to engage new business opportunities and develop proposals for scope of work. •Actively engaged with multiple clients to ensure GxP compliance of development and commercial product. Assess client program needs and manage through delegation of staff. Management of Client FDA 483 observations to assess and implement appropriate corrective actions and audit close out. •GMP and GLP audits in behalf of client supplier approval programs. •Liaison between client and CMO organizations to ensure adherence to GxP compliance for all stages of development, clinical trial supply and commercialization. Create, and manage quality agreements. •QA Lead for due diligence assessment of manufacturing facilities located in South America.