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Sartorius

Bioprocess and laboratory solutions provider

Manager of Quality - Complaints and Deviations

Validation, Compliance & Quality SystemsPosted on Nov 10
Full-timeYauco, Puerto RicoNo salary listed

About the Job

Requirements

  • A bachelor's degree in Engineering, Science, or a related field is required.
  • A minimum of 5 years of experience in Quality Management, including roles such as Supervisor, Manager, or other leadership positions, is required.
  • Strong proficiency in precision measuring tools and statistical analysis methods is required.
  • An in-depth understanding of quality assurance procedures and applicable regulatory standards is required.
  • Knowledge of regulatory requirements related to customer complaints and customer observations is required.
  • A solid understanding of Quality Management Systems (QMS) and associated management processes is required.
  • Advanced expertise in root cause analysis, investigations, change control, and CAPA management is required.
  • Experience in staff relations and team management is required.
  • Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook), Minitab, SAP, and computerized test analysis systems is required.
  • Fluency in Spanish and English is required.

Responsibilities

  • Oversee the intake, assessment, investigation, and closure of customer complaints to ensure timely and compliant resolution.
  • Manage the identification, classification, and investigation of deviations arising from manufacturing, laboratory, and operational activities.
  • Lead cross-functional teams in conducting root cause analyses to determine underlying drivers of quality issues.
  • Ensure the effective initiation, tracking, and closure of corrective and preventive actions (CAPAs) linked to complaints and deviations.
  • Maintain compliance with applicable regulatory requirements and internal quality standards across all complaint and deviation processes.
  • Monitor and analyze trends in complaints and deviations to identify recurring issues and support data-driven decision-making.
  • Collaborate with global and local teams to align processes, share best practices, and ensure consistency across sites.
  • Define, track, and report key performance indicators (KPIs) related to complaints and deviations to monitor performance and drive accountability.
  • Engage with internal stakeholders, including manufacturing, quality, and customer-facing teams, to ensure effective issue resolution.
  • Support internal and external audits by providing documentation, responding to inquiries, and addressing observations related to quality events.
  • Drive continuous improvement initiatives to enhance the efficiency and effectiveness of complaint and deviation management processes.
  • Provide training and ongoing guidance to personnel on procedures, systems, and best practices related to complaints and deviations.

Desired Qualifications

  • Certification and working knowledge of ISO 9001, ISO 13485, and regulated environments are considered a strong advantage.

About the Company

Sartorius

Bioprocess and laboratory solutions provider

Sartorius provides laboratory and bioprocessing equipment and services for biopharmaceutical development and manufacturing. Its products cover end-to-end needs such as bioreactors, single-use technologies, filtration and purification tools, analytics, and lab instruments, enabling researchers to grow, purify, and test biologics. The company differentiates itself with a long history, a broad, integrated portfolio, global support, and strategic acquisitions that expand its services under one trusted partner. Its goal is to help biopharmaceutical companies develop and produce biotech drugs and vaccines reliably at scale.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Göttingen, Germany
Founded
1870

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