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Quality Compliance Manager (Pharmaceutical)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Compliance Manager (Pharmaceutical): Maintaining and continuously improving the quality and regulatory compliance system at a pharmaceutical manufacturing site with an accent on GMP, regulatory requirements, quality systems, and patient safety. Focus on leading audits and inspections, managing CAPA and deviations, conducting risk assessments, and coordinating compliance investigations and remediation.
Location: Cali, Valle del Cauca, Colombia; onsite, full time
Company
develops healthcare products and solutions focused on improving healthcare delivery and sustaining lives.
What you will do
- Maintain and continuously improve the Quality and Regulatory Compliance System for the Cali manufacturing site.
- Develop and maintain quality policies, procedures, and processes aligned with regulatory requirements, including FDA and EMA regulations where applicable.
- Lead quality system activities covering document control, change control, deviation management, CAPA, training, audits, and inspections.
- Manage regulatory inspections and interactions with health authorities, including required reports and filings.
- Conduct compliance risk assessments, investigations, corrective actions, and remediation plans.
- Monitor KPIs, compliance metrics, regulatory developments, and improvement opportunities while collaborating with Quality Assurance, Regulatory Affairs, Manufacturing, and Research and Development.
Requirements
- 5–7 years of experience in Quality Assurance, Compliance, or Quality Systems Management in the pharmaceutical industry.
- 3–5 years of people management experience, including team leadership, development, and coaching.
- Degree in Pharmaceutical Chemistry.
- Advanced English preferred.
- Experience implementing regulatory compliance processes in a medium-to-large manufacturing facility or large program or department.
Culture & Benefits
- Work aligned with the mission to save and sustain lives.
- Culture focused on courage, trust, collaboration, ownership, and accountability.
- Commitment to product quality, patient safety, business continuity, and operational efficiency.
- Equal employment opportunity and reasonable accommodation support for candidates with disabilities.
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