Marybeth Gallagher Email & Phone Number

Florham Park, Nj

Vancouver, Bc, Ca

Leads the Zymeworks Clinical Quality Assurance team to ensure development and implementation of the Clinical Quality strategy, processes, procedures and standards. Establishes strong partnerships/ relationships with internal Zymeworks stakeholders to ensure that the clinical programs are adequately supported. Oversees clinical vendor audit and compliance monitoring programs by designing and implementing the clinical vendor audit plan in collaboration with Clinical Development; establishing the quality and compliance criteria; overseeing the evaluation of existing clinical vendors as well as qualifying new clinical vendors.Advises on strategic GCP questions and serves as a resource for ICH and FDA guidelines, and Clinical Operations SOPs.Assesses state of GCP compliance by supervising the analysis of audit program results, quality issues and investigations in order to optimize regional and global states of compliance. Provides appropriate risk analysis for key stakeholders to make critical decisions. Communicates state of compliance to executive management in Quality Management Reviews. Leads GCP-directed regulatory inspections and audits.

Florham Park, New Jersey, Us

Support clinical study teams by providing QA consultation for quality issues, advice on regulations, CRO sponsor oversight and clinical investigator site audits. Developed and delivered Inspection Readiness training based on ICH E6 R2. Ensure inspection preparedness by facilitating workshops based on FDA BIMO guidance targeted for those study teams a year prior to anticipated FDA inspection. Contribute to the annual GCP and PV tactical and strategic audit plans for vendors, systems and internal processes for the USA region. Prepare Master Audit Plans for clinical investigator site audits for all assigned clinical trials. Conduct audits according to the GCP, PV, and investigator site audit plans. Host PV vendor audits of Shionogi Inc. Support any regulatory inspections of Shionogi Inc in front or back room (as applicable to the inspection). Participate on TransCelerate and Shionogi internal ICH E8 R1 workstreams implementation activities. Responsible to establish the Sponsor Vendor Oversight ICH E6 R2 GCP model. Performed gal assessment then created and implemented tools, plan templates, and processes to ensure compliance with ICH, FDA and other applicable regulations. Host "CRO Oversight Forum" for sharing new Regulatory information, guidance, inspection trends, internal audit finding metrics, as well as other pertinent topics related to sponsor oversight. Established Key Quality Indicators and Quality Agreements with partner CROs.

Summit, New Jersey, Us

Facilitated inspection readiness activities and/or training of study teams in advance of an MHRA inspection. Led CAPA responses for QA audits of internal processes as well as inspections by MHRA, SwissMedic and FDA in collaboration with the business. Led end-to-end process mapping for critical processes in order to revise SOPs. Supported the integration of two acquired companies into the Quality Management department.

Summit, New Jersey, Us

New York, Ny, Us

New York, Ny, Us

South San Francisco, California, Us

Switzerland 🇨🇭 , Ch

Basel, Baselstadt, Ch

Switzerland 🇨🇭 , Ch