Sr Manager / AD of Global Quality Audit sought for this Biologics and Pharmaceutical Industry Leader to help lead compliance in all North and Latin American product markets
Initial Top Challenges:
1)Ensuring sites are prepared for Regulatory Agency Inspections. Special focus will be on FDA Pre-Approval Inspections readiness through FDA “Mock” inspections, audit and support activities and training
2)Provide compliance readiness within region in pharmaceutical technology for all product forms and with a particular emphasis on biological products, vaccines, zoning concepts, environmental monitoring, utilities and quality systems.
3)Lead Quality Audits in North and Latin American and present audit results to all levels of Site, Regional and Global Management.
4)Leading Corporate audits with a focus on the Six Systems approach in conducting an inspection (particularly Quality, Material, Production, F&E, Packaging & Labeling, Laboratory Systems)
5)Maintain strong relationships and continual dialogues with the FDA to make sure sites understand inspection findings, issues and emerging regulatory agency requirements.
Longer Term Challenges:
1)Participation in the development of comprehensive quality, auditing, audit certifications and inspection readiness training programs
2)Identify, promote and communicate “best practices” in auditing and compliance
Salary: Base will be DOE Bonus and relocation eligible too
Location: Flexible and close to an international airport. East Coast preferred
Travel: 40%-65% and primarily in the US and Latin America
Contact: Apply below and/or at www.fpccareers.com and/or contact Ira Mann at email@example.com
1) Experience working at the FDA as a CSO or with other GMP Inspectiopn responsibilites
2) B.S. degree (or advanced degree) in a scientific field.
3)7+ years combined experience in Pharmaceutical Quality, Auditing and FDA GMP inspections
4)Knowledge of US and Latin American regulatory requirements and cultures.
5)Ability to enter into highly different cultural and regulatory backgrounds worldwide with ‘diplomatic sensitivity’.
6)Knowledge of zoning concepts, environmental monitoring, utilities, quality systems, etc.
7)Ability to travel 40%-65% and throughout North and Latin America
1)Proficiency in English, Spanish and/or Portuguese
2)Knowledge of Biologics, Vaccines and/or other CBER regulated products
3)Broad experience across dosage forms and in pharmaceuticals, generics and biologics
Key Words: FDA, CSO, auditing, mock audit, PAI, zoning concepts, environmental monitoring 3PI, quality systems, GMP, biologics, vaccine, CBER, training
FPC - 20 months ago
Since 1968, FPC is the leading supplier of SUREBONDER® brand products. We manufacture and supply a complete line of high quality...