Job Description Summary

Job Description

Whatyoulldo:

• Accountable for ensuring full quality and regulatory compliance of a facility with regulatory GEHC PDx and GDP requirements/regulations while driving process effectiveness and efficiency at the site.
• Comply with the Technical Director functions in Colombia for PDx products (Drugs and Medical Devices) as stipulated in local applicable regulations.
• Act as deputy for Pharmacovigilance responsibilities in the assigned countries supporting the local and central Pharmacovigilance activities to comply with regulations in force.
• Ensures site audit readiness and hosts the Quality System audits and inspections (internal customer and regulatory); prepares and executes Quality Management System reviews.
• Maintains and improves all aspects of Site Quality Planning.
• Oversees all Quality-related communications and training requirements for all site employees.
• Maintains positive agency relationships-liaisons with regulatory agencies upon site inspections and participates in external technical forums.
• Oversees the Corrective Action / Preventive Action activities and Complaint Handling Programs Reports on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews.
• Drives the definition of site quality objectives metrics reporting and operating mechanisms.
• Ensures quality and regulatory compliance while driving process effectiveness and efficiency.
• Owns site compliance assessment and remediation plans while influencing site execution functional policy local research and development programs and communications and training requirements for Quality matters.
• Influences site compliance to Quality policy Quality Management System procedures and Quality Star guidelines.
• Influences quality system metrics such as Corrective and Preventive Action training metrics completion and complaint resolution metrics.
• Participates in selected global initiatives to share best practices and leverage quality synergies.
• Supports local NPI programs and quality issue resolution.
• Supports audits and oversight of third party suppliers distribution service providers (warehouses transport wholesaler/dealer channel partners etc.)
• Maintains positive relationships-liaisons with customers local distributors and other business partners

What you need to have:

• Bachelors Degree from accredited university or college of Science (Pharmacy)
• Minimum of 5 years working in a regulated pharmaceutical and/or medical device industry.
• Minimum of 1 year supervisory/management or project leadership experience
• Communicate effectively in English and Spanish (both written and oral).
• Demonstrated experience using word processing spreadsheet and presentation software.
• Demonstrated understanding or aptitude to understand Pharmaceutical and Medical Device QMS requirements and regulatory requirements including but not limited to INVIMA FDA CFR 21 820 ISO 13485 Good Distribution Practices (GDP) Good Laboratory Practices (GLP) Good Manufacturing Practices (GMP).
• Hands-on experience with INVIMA FDA QSR ISO MDD GDP GLP GMP and/or other local or international quality systems requirements.

Preferred Qualifications

• Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions.
• Proven process development and project management skills.
• Experience in a global matrixed organization structure.
• Demonstrated knowledge of Quality Management System tools continuous improvement methodologies & in-depth understanding of site level products & related processes.
• Experience leading implementing and accelerating change.
• Demonstrated collaboration & conflict resolution skills.
• Track record in performing & leading internal and external audits.
• Analytical problem solving & root-cause analysis skills.

Additional Information