Manages the auditing metrics program which involves tracking audit responses and auditee’s CAPAs until completion and closeout.
Manages audit activities which include audit agendas, audit reports and communicates finding to external and internal stakeholders.
Performs evaluations of quality systems and practices to identify potential problems such as non-conformance to applicable SOPs and quality standards (GMP, ICH, ISO, IPEC, etc.), coordinates resolutions, and provides guidance on quality/compliance risk levels.
Supports the audit program by independently conducting internal and external audits or participating as an audit team member.
Contributes to the development of the annual audit plans and schedules.
Collects, collates and evaluates applicable key auditing performance parameters for metrics report generation and presentation to management and stakeholders.
As related to Enterprise Quality Auditing Functions:
Responsible for the development and implementation of EQA programs, policies, procedures, agreements & controls.
Leads Mock PAIs of CMOs to prepare the facilities for audits and assess gaps in the system.
Organizes and leads periodic audit review meetings.
Provides guidance for continuous improvement to ensure compliance with regulations and current industry standards.
Evaluates metrics to determine trends and opportunities for continuous improvements. Assists in FDA inspections and may interact with regulatory authorities during regulatory inspections.
Minimum of a BA/BS with a minimum of 10 years’ experience in a pharmaceutical manufacturing or Quality Assurance/Compliance environment.
ASQ-CQA or ASQ-CQE certified highly desired.
Possesses strong technical and quality/compliance background related to pharmaceuticals/biologics.
Possesses thorough knowledge of current domestic and international standards and regulations related to pharmaceutical dosage forms/devices, (e.g., cGMP, GLP, ICH guidelines and guidance documents) and how to apply them to products pending release, and marketed products.
Has extensive experience and technical expertise in over 10 audit areas, such as API, Micro Lab, sterile drug product, Contract Pkg., Mock PAI, etc.
Demonstrates the ability to review investigations, change control, analytical data, test reports, batch records and certificates of analysis and other technical documents
Demonstrates the ability to conduct GMP audits of drug product and/or medical device manufacturers, as well as manufacturers of chemical raw materials and packaging components.
Demonstrates the ability to conduct focused quality incident investigations.
Able to use Word, Excel, Power Point and Outlook.
Excellent communication skills, both written and verbal.
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