In coordination with the VP of Corporate Quality, the other Regional Quality Directors, Quality Assurance and related peers within the Global Quality organization, the Director Regional Quality Assurance LATAM will work to lead the successful roll out and on-going compliance to Company’s  global quality and compliance systems, and associated procedures and standards. 

• Provide leadership and resource management support to Corporate Quality and Affiliates located within LATAM. 

• Ensure that our Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with US, LATAM, other global and local GMP, GXP and PV guidelines.  

• Ensure our organization is kept fully informed of new or emerging GMP and regulatory changes in LATAM and assess impact of regulatory change on Corporate policies and procedures. 

• Lead the review and implementation of Quality Improvement/remediation plans for LATAM Countries identified through GMP/GXP/PV audits 

• Provide Quality Expertise and leadership to the LATAM Countries and lead local/regional Quality activities.  Assure sites are in a state of inspection readiness and lead support during internal and external inspections/audits.  

• In collaboration with the Corporate Quality organization, weigh and communicate quality and compliance risks as appropriate 

• Monitor GMP, GXP and Pharmacovigilance compliance to regulations and company’s procedures and communicate CAPAs  and action plans to Country Management  and Global Corporate Quality 

• Act as Quality liaison between the local operational groups and Corporate Quality for GMP/GXP/PV functions and activities. 

• Partner with local, regional and global operational groups to foster a proactive approach to compliance. 

 

LATAM: Brazil, Colombia, Mexico and Argentina.