Senior Compliance and Regulatory Specialist

Job Description

The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. The ideal candidate must be agile and have well-developed organizational, interpersonal, compliance and practical application skills. This individual must be a self-starter, results oriented with the ability to receive, compile, analyze, disseminate, and articulate data and its implications at both site and broader program levels. This role has high visibility within the Somerset site and the greater organization as it touches various functional areas including: Supplier Quality, Regulatory Compliance, DEA, and QMS.

This role is part of the Clinical Development and Supply division which is part of the broader Pharmaceutical and Consumer Health Segment within the Company’s Pharma Solutions LLC business structure. This role is based out of the Somerset, NJ site.

SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
• Manage the supplier quality program and ensure Supplier Quality Management deliverables are met as required.
• Facilitate and host customer audits at the Company’s Somerset site to ensure compliance with cGMP’s, as well as Corporate and site standard operating procedures.
• Facilitate and participate in corporate internal audits to ensure compliance with FDA and applicable international health authority regulations.
• Lead the activities for preparing an oral solid dose manufacturing site for inspections by US FDA and applicable foreign regulatory authorities. Participate in all aspects of inspections from initiation, preparation, execution through closure.
• Lead the internal audit program at the site.
• Assist the site in preparing written responses to address the observations for customer audits, internal audits, corporate audits, and regulatory inspections. Ensure responses are completed as committed.
• Inform QA management where resolution of audit findings is inadequate or when audit commitments are not met.
• Initiate deviations when site procedures are not followed.
• Assist in preparing for PAI audits for new product approvals at site, compiling documents and reviewing to ensuring audit readiness.
• Participates in the preparation of Supplier and Customer Quality Agreements.
• Participate in global supplier and regulatory meetings and effectively represent the site.
• Review and approve TrackWise Records as needed acting as a QA Representative.
• Review and revise departmental SOPs as required.
• Comply with Environmental, Health & Safety requirements.
• Other ad hoc duties as assigned.

POSITION REQUIREMENTS:
Education & Experience:
• A bachelor’s degree with at least 5+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function
• Associate degree or High School Diploma with 10+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function

Knowledge:
• Knowledge of US FDA regulatory requirements as it pertains to solid oral dosage forms or prior experience working in a regulated field is required.
• Deep understanding of FDA and cGMP regulations pertaining to clinical and commercial pharmaceutical drug manufacturing activities is required.
• Understanding of various audit types (e.g. Customer, Supplier, Agency etc.) and techniques (e.g. Onsite, Questionnaire etc.) is preferred
• TrackWise experience is preferred.
• ASQ CQA or relevant Certification is highly preferred