Christine Caponigro

Quality Professional with over 30 years of experience in designing, implementing, and managing global quality systems and harmonized quality standards, contractor quality assurance, quality assurance internal/external auditing, licensed and clinical production support, and support of laboratories testing both licensed and clinical trial materials. Broad knowledge of GMP (US and EU), GLP requirements for manufacturing and testing both licensed and clinical products and for quality requirements for laboratories testing clinical trial materials in support of GCP (immunology);

experience with combination products and medical devices. Experienced domestic and international contract auditor. High performing verbal and written communication skills, experience and training in team building and conflict resolution skills.

Director, Global Quality Audit at AstraZeneca (2011 – Present)

Executes the AstraZeneca Operations internal and external audit program which includes focus on CGMP compliance and regulatory agency inspection readiness. The global scope includes compliance with current GMPs that cover worldwide regulatory agency requirements. We provide guidance for site GMP Compliance activities; collaborate with all global commercial and clinical manufacturing sites on GMP compliance and inspection readiness.

Advise QA management on external environment and strategic compliance trends impacting our business. Sponsors and champions compliance improvement projects / programs across global AstraZeneca small and large molecule manufacturing sites. Interfaces directly with global QA teams and QA leadership; actively influences and participates on global QA initiatives from a GMP compliance perspective.

Recommends solutions to complex quality issues and works closely with senior compliance and quality management to resolve significant compliance trends and issues. Function as GQA eLMS Administrator and Training Team Lead as part of continuous improvement.

• Designed and implemented an Auditor Qualification program across AstraZeneca for Self-Inspector Qualification across AstraZeneca.
• Designed and implemented a Regulatory inspection readiness and support program across MedImmune which has been adopted and implemented globally within AstraZeneca including mock PAI
• Designed and built job specific curriculum for GQA personnel within the AZ eLMS.
• Continue to manage and improve GQA curriculum within the AZ eLMS while aligning with and driving best practices across the enterprise.

Deputy Director of R&D Quality Assurance at SANOFI PASTEUR (2002– 2011)

Directly manage the R&D quality systems: change control (system owner), deviation investigations (system owner), internal/external audit programs (SME), and CAPA. Designed and implemented the initial deviation investigation and change control systems for Phase I, II and III clinical products. Collaborate with the site commercial quality organization, the global R&D quality organization, and the R&D customer groups to align quality requirements and align quality systems.

Provide expertise and guidance to new vaccine project teams. Directly responsible for oversight of quality within the new vaccine analytical testing groups, the clinical immunology group in support of clinical trials and assay validation program. Instituted a global enterprise standard for GCLP (Good Clinical Laboratory Practices).

Support all Regulatory inspections and inspection readiness programs within R&D. Implemented global quality systems supporting contract clinical manufacturing and testing services between US, FR and CA. Identified and authored global standards for quality in laboratories performing testing in support of clinical studies in collaboration with the customer groups.

Provide quality training for new employees for orientation and ongoing GXP training. Lead and participate in key site and global R&D projects. Support the global GLP group by facilitating NA initiatives/activities, performing, and supporting audits/inspections, acting in a local advisory role and participating in global R&D QA GLP initiatives.

• Led a team to author and implement global standard for GMP in R&D defining phase appropriate quality standards for Phase I through Phase III.
• Established a supplier quality program and cross functional team between GCP/GLP and Commercial and R&D GMP Quality.

Quality Assurance Senior Compliance Official (Commercial Quality Assurance) at SANOFI PASTEUR (2000 – 2002)

Responsible for GMP internal and external audit management and performance. Administration of quality systems for deviation investigations, change control and CAPA. Responsible for training personnel on site quality systems. Support and coordination of domestic and international Regulatory inspections. Directly responsible for oversight of quality within the commercial manufacturing and testing groups. Participate in and support successful inspections for licensure of new products.

• Compliance lead for the successful AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International) certification of QC laboratories.
• Implemented a global cross functional Auditor Qualification program. Delivered auditor training and quality orientation training to new employees.

Development Technician (Product Development) at SANOFI PASTEUR (1996 – 2000)

Experience in controlled fermentation (both small and large scale), facility, equipment, and process validation. Responsible for development and testing of analytical methods for developmental products in process (e.g., SDS Page, PHASTGEL, metabolite analysis). Performance, optimization and scale up of purification techniques including HPLC, FPLC, ultracentrifugation, and diafiltration.

Experience in aseptic technique, reagent preparation and sterilization and technical writing.

• Directly contributed to setting standards of quality for clinical products within R&D in SWF.
• Significant contributor to the qualification of large scale clinical sterile filling process and the isolator barrier filling system in the Pilot Plant.

Laboratory Technician Level 2 (Commercial Production) at SANOFI PASTEUR (1994– 1996)

Experience in all aspects of large-scale purification including diafiltration, conjugation, column chromatography, derivitization, ultracentrifugation.

Experience in all aspects of large-scale upstream manufacturing (i.e., fermentation).

Assistant Office Manager at East Stroudsburg Veterinary Hospital (1992– 1994)

Veterinary Assistant at East Stroudsburg Veterinary Hospital (1990– 1992)

B.S. in Biology – East Stroudsburg University