Ardena Careers · 3 months ago
Senior Regulatory and Compliance Specialist
Somerset, NJ
Contract
Onsite
Mid, Senior Level
$100K/yr - $120K/yr
5+ years expArdena is a leading Contract Development and Manufacturing Organization (CDMO) that partners with pharmaceutical companies to assist in drug development. They are seeking a Senior Regulatory and Compliance Specialist who will ensure compliance with global regulations, facilitate audits, and prepare for inspections related to pharmaceutical manufacturing processes.
Pharmaceuticals
Responsibilities
Facilitate and host customer audits at the Somerset site to ensure compliance with cGMP’s, as well as international regulatory compliance 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
Assist in preparing for PAI audits for new product approvals at site, compiling documents and reviewing to ensure audit readiness
Review and approve Quality Management System Records as needed acting as a QA Representative
Qualification
Required
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 functions
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 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
Soft skills that align with our CARE values- Communicative, Accountable, Reliable, and Excellent
Preferred
Understanding of various audit types (e.g. Customer, Supplier, Agency etc.) and techniques (e.g. Onsite, Questionnaire etc.) is preferred
Demonstrated experience with customer and internal audits is preferred
Demonstrated experience with Health Authority Inspections (front or back room) is highly preferred
Benefits
Medical, dental and vision benefits effective day one of employment
Paid Time Off
A dynamic, global work environment with career growth opportunities
Access to Ardena Academy, our internal learning platform for professional development
A chance to contribute to groundbreaking drug development projects that make a real impact
Company
Ardena Careers
Find your career path with Ardena At Ardena, we’re more than a global Contract Development and Manufacturing Organization (CDMO)—we’re a team of innovators, problem-solvers, and experts dedicated to advancing drug development.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase