Senior Audit Specialist Job in Spring House, Pennsylvania US
Johnson Johnson Pharmaceutical Research Development, L.L.C. (PRD), one of the Janssen Pharmaceutical Companies of Johnson Johnson, is recruiting for a Senior Audit Specialist, Global System Quality Assurance, Global RD QA to be located in Spring House, PA or Titusville or Raritan, NJ.
Johnson Johnson Pharmaceutical Research Development, L.L.C. develops treatments that improve the health of people worldwide. Research and development areas encompass novel innovative, effective treatments for central nervous system disorders, pain, diabetes and cardiovascular diseases.
The Senior Audit Specialist, GSQA is responsible for the independent planning and conduct of audits of Good Clinical Practice (GCP), pharmacovigilance and computerized system activities of the JJ pharmaceutical sector worldwide, including JJ Operating Companies (including Consumer for pharmacovigilance), business partners and vendors affiliated with safety reporting or GCP activities. These audits provide an independent quality assessment to ensure compliance with appropriate regulations, SOPs, processes, etc. as they pertain to company-sponsored research and post-marketing pharmacovigilance activities. The Specialist will prepare and effectively communicate audit report findings, conduct the critical review of documents, procedures, facilities, etc., to ensure accuracy for acceptance by International Regulatory Agencies. They will serve as a consultant to business partners and the operating companies, assist with facilitation of inspections by regulatory authorities for GCP, pharmacovigilance and GLP (computerized systems only) and monitor new regulatory legislation or guidelines, which have direct impact on GCP, pharmacovigilance or computerized systems regulatory compliance activities.
The Senior Audit Specialistwill independently lead in the planning and conduct of system based audits of the GCP, pharmacovigilance and computerized systems activities of the JJ pharmaceutical sector worldwide, including JJ Operating Companies (including Consumer for pharmacovigilance), business partners and vendors to assure adherence to corporate policies, internal standards/requirements and compliance with regulatory requirements. They will issue reports of audit findings, effectively communicate these findings and track corrective action plans through implementation and verification and perform peer review of audit reports as appropriate to function. They will assess current quality of GCP, pharmacovigilance and computerized systems related systems, make recommendations for improvement and contribute to process improvements and ongoing development of new auditing procedures, techniques and department guidelines. They will also write or revise RD QA SOPs and contribute to the development and revision of other departmental SOPs.
The Senior Audit Specialistwill routinely interact with internal/external appropriate functional personnel, to identify issues and recommend actions as solutions to issues identified throughout the inspection/audit process. They will take action on solutions of moderate regulatory and technical complexity and seek supervisor's advice on issues of difficult complexity. They will monitor new regulatory legislation or guidelines, which have direct impact on GCP, pharmacovigilance or computerized systems regulatory compliance activities and where appropriate disseminates this information to members of other functional areas such as Benefit Risk Management (BRM), Regulatory Affairs, and Global Clinical Operations and Preclinical Development. They will also assist in the facilitation of inspections by regulatory authorities for GCP, pharmacovigilance or GLP (computerized systems only).
The Senior Audit Specialistwill act as a subject matter expert in GSQA, and respond independently to GCP, pharmacovigilance or computerized systems related compliance inquiries from other departments on complex issues. They will confer with professional staff when contacted for proactive consultation to provide regulatory insight regarding specific issues or special circumstances identified by professional staff to obtain a department unified position. They will also participate in special projects related to quality assurance functional issues, as assigned by supervisor, support Licensing and Acquisition GSQA Due Diligence assessments and may attend project team meetings as needed and communicate outcomes to supervisor.
Qualifications
A minimum of a Bachelor's degree is required. A minimum of 4 years of experience in a specific compliance area and/or equivalent time and experience in a related RD area is required. Comprehensive knowledge in a specific compliance discipline (GLP, GMP, GCP, PV or Computer Systems Compliance) and comprehensive knowledge of the drug development process, regulation awareness and scientific terminology is strongly preferred. Understanding of pre-clinical/clinical or systems validation documentation and regulatory records are highly desired. Technical background and understanding to assure that the reported results from studies/systems accurately reflects raw data is required. Knowledge of SOPs and documentation requirements in a regulated industry is required. Experience auditing in a GCP, PV, or Computer Systems Compliance environment is preferred.
Excellent negotiation and influencing skills are required. Strong organizational, auditing and problem solving skills and established networking experience is required. Excellent written and verbal communication skills are required. Effective time management skills and the ability to manage multiple projects simultaneously is required.
Position requires up to 30% travel, both domestic and international and will be based in Spring House, PA, Titusville, NJ or Raritan, NJ. In addition, there could be a need for local travel to any of the three sites.