Experience

Uniquity Bio

• Biotechnology Research
• 1 - 100 Employee

• Vice President, Quality & Compliance

  • Apr 2022 - Present

  United States Formerly known as Nexstone Immunology



Marinus Pharma

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Vice President, Quality Programs

  • Oct 2019 - Apr 2022

  Radnor, PA



Patricia A. Ward

• Quality Assurance Consultant

  • Sep 2019 - Apr 2022



Aclaris Therapeutics, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Executive Director, Quality Assurance

  • Oct 2016 - Sep 2019

  Malvern, PA USA Responsible for the management and ongoing compliance of the company's research and development programs governed by current GMPs, GLPs and GCPs. Development and maintenance of procedural documents and audit programs of third party vendors in the areas of CMC, toxicology and clinical development.



Quality Assurance Consultant

• QA Consultant

  • Jul 2015 - Sep 2016

  Greater Philadelphia Area Conduct a full range of GXP and PV audits for global clients in the pharmaceutical and biotechnology industries. • Established a client base of over 40 international clients • Established and maintained a robust network through 25+ years in the regulated R&D space • Provide compliance guidance and strategy for clients prior to their implementation of an internal quality function



Shire

• Japan
• Biotechnology Research
• 700 & Above Employee

• Director, R&D Quality Assurance

  • Jun 2012 - Jul 2015

  Chesterbrook, PA Developed and lead QA auditing/inspection/compliance strategies for GCPs, PV, LOCs/affiliates and internal processes and other regulated and high-risk R&D activities. Provided in-depth analysis and risk-management for compliance and quality-related matters and recommended solutions, corrective and preventative actions.



Quality Assurance Consultant

• QA Consultant

  • Sep 1999 - Jun 2012

  Greater Philadelphia Area Conduct a full range of document, clinical investigator sites, systems/processes and vendor/on-site audits for global clients in the pharmaceutical and biotechnology industries. Clinical on-site audits include FDA preparation, routine and “for-cause” (directed) inspections. Document audits include: nonclinical, bioanalytical, bioequivalence and clinical study reports; integrated summaries, Product Safety Update Reports, Investigator Brochures, protocols and informed consent documents. GMP… Show more Conduct a full range of document, clinical investigator sites, systems/processes and vendor/on-site audits for global clients in the pharmaceutical and biotechnology industries. Clinical on-site audits include FDA preparation, routine and “for-cause” (directed) inspections. Document audits include: nonclinical, bioanalytical, bioequivalence and clinical study reports; integrated summaries, Product Safety Update Reports, Investigator Brochures, protocols and informed consent documents. GMP audits include IMP manufacturing, packaging and distribution facilities/vendors. Conduct regulatory or specialized training. Show less



AstraMerck

• Compliance Advisor

  • 1996 - Sep 1999

  Chesterbrook, PA Manage/conduct assessments of internal processes and systems. Coordinate/conduct compliance training for client groups (Clinical Operations, IT/IS, Regulatory Operations). Manage the review and distribution of relevant compliance information. Managed resource allocation for audit and training activities. Develop auditing and inspection strategies for Quality Assurance functions. Plan and execute audit strategies to evaluate and maintain compliance to FDA regulations and applicable… Show more Manage/conduct assessments of internal processes and systems. Coordinate/conduct compliance training for client groups (Clinical Operations, IT/IS, Regulatory Operations). Manage the review and distribution of relevant compliance information. Managed resource allocation for audit and training activities. Develop auditing and inspection strategies for Quality Assurance functions. Plan and execute audit strategies to evaluate and maintain compliance to FDA regulations and applicable international regulations/standards. • Develop evaluation criteria and tools for auditing contracted support services • Perform pre-placement, in-process inspections and report reviews of drug development activities • Function as a liaison for regulatory agency inspections • Represent Compliance/Quality Assurance initiatives on core product/process teams • Develop and maintain SOPs and associated reference guides applicable to appropriate regulatory requirements and the quality assurance program • Provide necessary education and training programs on appropriate GCP, GLP, or GMP requirements/concepts • Plan and conduct internal audits of regulatory submissions Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manager R&D QA - Animal Health Division

  • 1994 - 1996

  Exton, PA Ensure US/Canada Pharmaceutical R&D compliance with GCP, GLP, and GMP, USDA Animal Welfare and DEA Controlled Substance Regulations worldwide by performing the following: • Interpret EPA GLP and FDA GCP, GLP and GMP Regulations, USDA Animal Welfare Regulations and DEA Controlled Substance Regulations • Develop procedures to ensure GMP/GLP/GCP compliance • Manage compliance aspects of all INAD/NADA support studies conducted on site or sponsored by site • Participate in EPA, FDA and… Show more Ensure US/Canada Pharmaceutical R&D compliance with GCP, GLP, and GMP, USDA Animal Welfare and DEA Controlled Substance Regulations worldwide by performing the following: • Interpret EPA GLP and FDA GCP, GLP and GMP Regulations, USDA Animal Welfare Regulations and DEA Controlled Substance Regulations • Develop procedures to ensure GMP/GLP/GCP compliance • Manage compliance aspects of all INAD/NADA support studies conducted on site or sponsored by site • Participate in EPA, FDA and USDA inspections dealing with GMP, GLP and GCP regulations • Manage departmental workload to ensure work is processed to an appropriate and consistent standard and meets agreed upon target dates • Coordinate and conduct site training programs to meet regulatory and group/individual needs • Provide compliance advice and coordinate departmental participation in computer validation efforts across R&D departments at site Show less



Greenwich Pharmaceuticals

• QA Manager

  • 1992 - 1994

  Ft. Washington, PA Develop and implement quality systems for internal and external audits, documentation and SOP review/approval and product release. Assess bulk chemical manufacturers (domestic and international) for compliance with GMPs and company standards. Ensure internal compliance with GLPs by reviewing protocols, reports, SOPs, facilities and operations. Assess contractors for compliance with GLPs and company standards. Ensure internal compliance with GCPs by reviewing protocols, CRFs, SOPs and reports… Show more Develop and implement quality systems for internal and external audits, documentation and SOP review/approval and product release. Assess bulk chemical manufacturers (domestic and international) for compliance with GMPs and company standards. Ensure internal compliance with GLPs by reviewing protocols, reports, SOPs, facilities and operations. Assess contractors for compliance with GLPs and company standards. Ensure internal compliance with GCPs by reviewing protocols, CRFs, SOPs and reports. Monitor compliance of investigators. Maintain employee files for review by external agencies. Review dossiers for submission to US and foreign regulatory agencies. Review protocols and reports for computer validation. Responsible for internal compliance to GMPs through implementation and review of batch records, systems and procedures for clinical and market supplies. Perform external audits of contractors for compliance with GMPs and company standards. Show less



SmithKline Beecham Corporation

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Compliance Advisor

  • 1989 - 1992

  Upper Merion, PA Review protocols, data and final preclinical safety study reports for IND submissions. Ensure that studies were conducted in accordance with the protocol, SOPs and GLPs. Schedule and conduct facility and operations audits. Audit production of clinical supplies to ensure compliance with SOPs and GMPs. Prepare confidential reports describing audit findings and corrective actions. Review equipment/computer validation protocols and reports. Perform contract/vendor audits. Perform GLP/GMP training.

• Scientist Large Cell Culture

  • 1988 - 1989

  Upper Merion, PA



E.I du Pont

• Cell Biologist

  • 1987 - 1988

  Delaware



Centocor

• Biotechnology Research
• 400 - 500 Employee

• Supervisor, Cell Culture

  • 1985 - 1987

  Malvern, PA