HireDiversity

Fort Washington, PA, US

Senior Audit Manager, GxP - IT-6671130110

Description

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies Inc. is currently recruiting for a Sr. Audit Manager, GxP - IT located in Fort Washington, PA.

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. develops and markets baby care, wound care and skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brands JOHNSON'S® Baby and BAND-AID® Brand, as well as leading skin care brands such as AVEENO® and CLEAN & CLEAR®.

The primary responsibility of the Sr. Audit Manager, GxP - IT is to execute GxP-IT (GMP, GCP, GLP; Information Technology Audits) Compliance and global risk assessment audits to assure compliance with international/regional regulations (e.g., CFR 21, Part 11, ICH, cGMPs). Other major responsibilities include: leading audits and teams, training auditors & subject matter experts (SMEs), maintaining the audit database, issuing audit reports, communicating compliance issues to corporate quality management, and assisting in the development of compliance policy/procedures and internal training packages/presentations. This individual will conduct (or lead the audit team conducting GxP-IT Audits) IT process and compliance audits. The selected candidate will be responsible for planning, scheduling, team selection, and conduct of GMP compliance audits and for the communication of audit findings. This individual is responsible for ensuring audit schedules are followed and revised upon management approval, audit metrics are met. The Audit Manager is also responsible for evaluating corrective and preventive actions resulting from audit findings and verification of the corrective and preventive actions. This individual will also conduct IT compliance audits at McNeil sites (includes biologics and R&D), by leading audit teams or serving as an audit team member, in accordance with internal policies & standard auditing practices.

The Sr. Audit Manager, GxP-IT will perform tracking, reporting, verification, closeout, and trending of audits performed & associated responses. Provide guidance/support in CAPA development & determine response adequacy. The selected candidate will also interface with Quality Management throughout the McNeil Consumer Companies, to assist in organizing audit teams and to perform GXP-IT audits, in accordance with the annual audit schedule and defined audit plan. This individual will support global, regional, and local Quality/Compliance Management, in preparation for regulatory agency inspections/audits; Facilitate regulatory interactions; Assist in remediation & gap analysis. The Sr. Audit Manager will also communicate trending, metrics, and compliance issues to Global Quality Management as well as assist in the standardization of policies, procedures & training and the development of training packages/presentations for the GCA (Global Compliance Audit) and related Quality/Compliance organizations (e.g., investigations). The selected candidate will interface with the GxP-IT Quality/Compliance Management of Third Party suppliers/vendors, and participate in external audits, as needed and be responsible for independently research pharmaceutical industry trends and updates. This individual will support Global Quality Management & promote quality compliance initiatives, as needed and will also independently research Information technology (e.g.: SAP, PAT) related pharmaceutical industry trends, practices, and updates.

Qualifications


A minimum of a Bachelors degree is required. A focused degree in a scientific or healthcare field or a closely related discipline is preferred. It is required to have a minimum of 7 years of general work experience within the pharmaceutical, OTC and/or Medical Device & Diagnosis industry. A minimum of at least 5 years of work experience in a heavily regulated GxP environment OR external manufacturing Information Technology environment (Quality Assurance, Quality Control, Manufacturing departments) is required. Experience working in the Pharmaceutical or Device industry in a GxP-IT role performing Computer System Validations is required. Detailed understanding of industry auditing practices to FDA GMP (21 CFR part 11, 58, 210, 211, 820) is required.

Knowledge of drug and/or device regulations and a demonstrated ability to analyze and interpret regulatory documents is required. This candidate must have strong interpersonal skills and must have a demonstrated ability to be an effective, confident communicator in internal and external settings, across various regions and levels of an organization. Good interpersonal, verbal communication and writing skills are required. This individual must have the ability to observe processes and interpret compliance risks. It is required to have the ability to influence and negotiate without direct line authority. This candidate must also be able to uphold the strong compliance values with external providers. Industry/trade certifications or experience are preferred (ASQ, PDA, ISO, CISA, etc.). Six Sigma Process Excellence knowledge, training and/or certification is preferred.

This position will be based in Ft. Washington, PA and may require up to 50% domestic and international travel.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: Johnson & Johnson Consumer Inc. (6071)