Sanofi Group Associate Director, Global Quality Audit in Bridgewater, New Jersey
Associate Director, Global Quality Audit
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme.
At Sanofi US, we are committed to the growth of our people, connected in purpose by career, life and health.
Headquartered in Bridgewater, NJ, Sanofi US is part of a leading global healthcare company dedicated to discovering, developing and distributing therapeutic solutions focused on patients’ needs.
Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme.
Sanofi US employs approximately 17,000 people across the country all dedicated to protecting health, enhancing life and responding to the hopes and potential healthcare needs of seven billion people around the world.
Commitment is our Strength. Ready to grow together?
Sanofi US endeavors to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-800-207-8049 Option 7, then Option 3.
JOB DESCRIPTION - Associate Director, Global Quality Audit
The role ensures that Sanofi-Aventis Quality and Compliance Standards and applicable Government Regulations are met and that all Sanofi-Aventis sites and third parties achieve, maintain and improve the current level of compliance through independent auditing and follow-up of Sanofi-Aventis sites.
Ensure that sites are prepared of Regulatory Agency Inspections, especially FDA Pre-Approval Inspections, through FDA "Mock" inspections, audit and support activities and training.
Prepares and maintains the schedule of IACS audits
Plans, prepares and performs audits according to the schedule.
Prepares Executive Summaries, issues lists and audits reports based upon the above and distribute to the relevant personnel.
Performs routine follow up of performed audits in conjunction with site management
Gives immediate support in the form of possible corrective actions during the audit, and contribute to management decisions in this respect.
Provides effective and timely reporting of compliance status of the respective sites to the Head of IACS and update the relevant IACS presentation
Ensures the establishment of an appropriate timescale of corrective actions in cooperation with the audited sites, and support follow-up as agreed with and in conjunction with the Operational Units.
Participates in the planning, review and approval of GMP related issues of new or remodeled facility layouts, including IQ/OQ/PQ validation activities.
Maintains own knowledge of current IQC Policies, Standards and Guidelines as well as Industry practices and incidents, Regulatory requirements, and all other related information.
Keep documented records of training received.
Supports and participates in training efforts as requested by Operational Units and/or sites, including PAI preparation training and Auditor Certification training.
Develops a "pool" of auditors throughout the Sanofi-Aventis group.
Minimum Bachelor’s of Science or equivalent with at least 10 years relevant experience in the Pharmaceutical Industry or a major Regulatory Authority.
Prefer fluency in English OR French plus Spanish or Portuguese
Strong communication skills
Risk-Controls and Management
GMP/ GDP Regulations i.e. ANSM, USFDA, EU, WHO
Certified auditor with experience in GMP/ GDP compliance
Quality Compliance and Regulatory Inspections
Continuous Process Improvements Methodology
Thorough experience in auditing or inspecting regulated healthcare sectors
Operational Experience in at least one technical field: Quality or Production Biologics OR Vaccines OR Combination Products Medical Devices OR Injectable Medicinal Products for Human Use
Thorough experience in GMP/GDP Regulatory Inspections USFDA & EMA
Advanced knowledge of regulations applicable to Medicinal and Medical Device products for Human Use
In-depth knowledge of Pharmaceutical Operations. #LI-SA
Primary Location: United States-New Jersey-Bridgewater
Job Posting: Oct 12, 2016, 6:32:10 AM
Job Type: Regular
Employee Status: Regular