Lead, coordinate, verify and track global compliance activities within the pharmaceutical division
Evaluate Investigations and Changes impacting regulatory commitments
Identify and remediate plant quality and compliance risks
Support plant strategies and compliance plans for identified gaps
Prepare manufacturing sites for US-FDA inspections
Perform mock inspections and evaluate plants’ readiness
Train plant staff for FDA inspection aspects and behaviors
Participate and support during US-FDA inspections including immediate guidance
Identify new FDA cGMP trends and develop strategies for compliance
Prepare global quality management documents
Collaborate with corporate quality functions on strategic goals
Communicate findings and risks to management

Minimum of Bachelor’s degree required
Advanced degree in chemistry, molecular biology, microbiology or engineering field is highly desirable
8+ years of experience in pharmaceutical industry and/or US-FDA
Thorough knowledge of drug transfer processes and cGMPs
Professional experience in pharmaceutical industry including technical understanding of manufacturing pharmaceuticals
Prior experience in executing and/or managing GxP audits or inspections
Ability to effectively interact with plant personnel and leadership
Strong analytical problem-solving experience
Ability to manage multiple complex situations
Ability to travel frequently (both domestically and internationally)
Project Management and strong communication skills required
Bilingual English/Spanish preferred

401(k) plan with company contributions
Paid vacation
Holiday and personal days
Employee assistance program
Health benefits including medical, prescription drug, dental and vision coverage

Senior Manager, GxP Compliance Officer

Key skills