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4 дня назад

Quality Assurance Senior Manager (Pharmaceutical Quality)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
c1
Страна
Colombia
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Quality Assurance Senior Manager (Pharmaceutical Quality): Leading quality assurance and technical direction for pharmaceutical and healthcare products in Colombia with an accent on regulatory compliance, GMP, quality management systems, and product release. Focus on managing audits, CAPAs, quality incidents, risk-based decisions, and developing the Quality team across regional operations.

Location: Bogota General Office, Colombia

Company

Consumer goods company operating globally with a portfolio of trusted brands and healthcare products.

What you will do

  • Lead Quality Assurance and Technical Direction activities for the PHC portfolio in Colombia and support Quality operations across LADMAR.
  • Ensure compliance with local regulations, Good Manufacturing Practices, and Good Storage and Distribution Practices.
  • Oversee product release and quality disposition for pharmaceuticals, dietary supplements, cosmetics, food products, medical devices, and diagnostic reagents.
  • Maintain and improve the Quality Management System, including deviations, CAPAs, change controls, risk management, and quality documentation.
  • Lead internal, external, supplier, and health-authority audits and manage product complaints, recalls, returns, rejections, and critical quality incidents.
  • Lead and develop the Quality team while partnering with Supply Chain, Regulatory Affairs, suppliers, third-party logistics partners, commercial teams, and health authorities.

Requirements

  • Licensed Pharmaceutical Chemist with valid professional registration permitting Technical Director responsibilities in Colombia.
  • At least 5 years of relevant experience in Pharmaceutical Quality Assurance, Technical Direction, Production, Regulatory Affairs, and/or Quality Control.
  • Strong knowledge of Quality Management Systems, GMP, Good Storage and Distribution Practices, and pharmaceutical regulatory requirements.
  • Experience managing quality deviations, CAPAs, audits, risk assessments, and product quality decisions.
  • Experience with pharmaceutical and/or healthcare product regulatory matters, strong analytical skills, and effective stakeholder management.
  • Advanced English proficiency required.

Nice to have

  • Experience in a regional or multi-country Quality Assurance environment.
  • Exposure to INVIMA or other health authorities.
  • Experience with 3PL warehouses, suppliers, distributors, and external manufacturing or logistics partners.
  • Experience across pharmaceuticals, medical devices, cosmetics, dietary supplements, or diagnostic reagents.
  • Previous experience leading or developing Quality teams.

Culture & Benefits

  • Ownership of projects and responsibilities from the first day.
  • Formal training, continuous mentorship, and day-to-day guidance.
  • Dynamic and supportive work environment.
  • Flexible work scheduling, work-life balance, and support for long-term well-being.
  • Competitive salary and benefits package.

Hiring process

  • Online assessments are part of the recruitment process.
  • Reasonable accommodations are available for candidates with disabilities during assessment and selection stages.

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