Quality Assurance Leader Colombia & CALA GEHC PDx
Job Description
Job Description Summary
Responsible for ensuring PDx Quality and Regulatory compliance of PDx in Colombia and CALA countries while driving process effectiveness and efficiency.The Quality Assurance Leader represents GE Healthcare PDx Diagnostics to external agencies and champions evolution of the quality culture for the site which includes executing and driving site quality objectives, metrics, reporting and operating mechanisms. Work closely with the Global Quality team to ensure compliance with Good Distribution Practices, Quality Management System and local regulations: INVIMA and others as applicable.
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.
Job Description
GE HealthCare is a leading global medical technology and digital solutions innovator with over 100 years of healthcare industry experience and around 50,000 employees globally.
We enable clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications, and services, supported by our Edison intelligence platform. We operate at the center of an ecosystem working toward precision health -digitizing healthcare, helping drive productivity and improving outcomes for patients, providers, health systems and researchers around the world.
What you’ll do:
- 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:
- Bachelor's 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.
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.
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Additional Information
Relocation Assistance Provided: No