Regional QA Manager, Latin America & Canada (LAC)

Job description

     

JOB DESCRIPTION:

Primary Job Function:

The incumbent leads the quality efforts of the region in support of the commercial affiliate organization are related to compliance with Quality System Management and local regulations in each of the countries within the Area. 

The role is responsible for development, training, implementation and monitoring of quality systems for the whole ADD Commercial organization to ensure full compliance with all laws, regulations, policies and standards. This is achieved through assuring compliance with Division QA policies applicable to Commercial Affiliates and working within Global Commercial QA Organization peers to maintain a global Quality System aligned with Division requirements.

Core Job Responsibilities:

·  Establish and aggressively drive the Global Commercial QA strategy for the Latin America & Canada region by taking ownership and aligning with key Global ADD LRP strategies and direction.
·  Ensure consistent application of Division QA policies, programs, and systems related to activities performed by the Commercial Affiliates (Sales, Marketing, Logistics/Warehouse, Field Repair Centers and Service) by clearly defining specific requirements and locally developed procedures that govern critical to success business functions. Recognition that some degree of flexibility to execute activities appropriate to local requirements and market needs is also required.
·  Work within region to assist affiliates being compliance, support audit readiness for internal and external audits, responses and appropriate corrective actions.  Review affiliate audits and evaluate regional and global potential risk, assuring any similar deficiencies at other affiliates are also addressed worldwide.  
·  Establish effective partnerships with the business locations to ensure regional QA needs are identified and successfully met. The role is also leading projects for continuous improvement of the Quality Systems of Commercial Affiliates.
·  Perform Management Reviews with the Commercial Area  LAC  and provide input for Executive Management Review of ADD.Facilitate the Management Review process at Area level, develop and maintain QA KPI’s/Metrics as inputs into the Management Review processes aligned with the other Areas worldwide (e.g. EMEA, Asia Pac) and elevate any issue from the countries to VP of Area as needed. 
·  The position may require the incumbent to build effective relationships with local regulators, agencies, and trade organizations to influence direction of regulations, requirements, and performance expectations.
·  Work with affiliates to assist in local assessments (if applicable) for new partners (e.g. distributors/3PL and other suppliers) and help ensure processes are in place at those partners to maintain product and process quality. 
·  Perform Gap Analysis to help drive consistency between affiliates in the region and manufacturing facilities. Evaluate and interpret industry regulations and division policies and develop strategies for ensuring affiliates are compliant.

Supervisory/Management Responsibilities:

All quality representatives in the affiliate location within the LAC area will directly report to this position.

Skills/Experience:

·  Medical device, Pharmaceutical or related industry experience (3+ years) in a QA or Business Excellence (BEx) Role
·  Regional/Global experienced in Latin America preferred
·  Ability to communicate effectively in spoken and written English; Spanish and Portuguese (spoken/written) would be an added advantage
·  Ability to develop problem resolution plans that consider both project variables and potential intangible events so that critical to success deadlines are routinely achieved.
·  Must possess a high degree of responsibility and deep sense of ownership for ensuring the highest level for QA standards.                                                                 
·  Position will require the ability to rapidly retrieve existing standard operating procedures (SOPs), deploy them as required to facilitate commercial business operations and in some cases develop procedural solutions to appropriately resolve quality and compliance challenges across various business unit functions in the Latin America region and consider global impact.
·  Desired skills/experiences include:
·  Familiarity with regulations such as ISO 9000/13485, QSR for IVD and Biologics
·  Change management
·  Experience in working with matrix organizations
·  Program/project management
·  Cross-functional/cross-divisional experiences
·  Applicable technical knowledge/experience
·  Audit evaluations and CAPA resolution planning
·  Ability to develop procedures and policies that clearly define efficient and effective processes needed to ensure compliance and resolve identified problem.
·  Experience in leading and participating in cross-functional teams tasked with QA problem resolution
·  Experience in training curriculum development

·  Ability to travel 20-30% of the time

Education:

·  Bachelor's degree minimum, in science, technical or business-related discipline or substantial equivalent experience

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ADD Diagnostics

        

LOCATION:

Colombia > Bogota : Building II

     

ADDITIONAL LOCATIONS:

Brazil > Sao Paulo : Building 1

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 20 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Keyboard use (greater or equal to 50% of the workday)