Quality Systems and Compliance Manager
Listed on 2025-11-20
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Quality Assurance - QA/QC
Data Analyst
Job Responsibilities
Build, maintain, and oversee a quality system that aligns with industry expectations for regulated manufacturing and distribution environments.
Manage core quality processes, including documentation oversight, revision control, deviation tracking, corrective actions, and training coordination.
Lead internal review activities, support external partner audits, and assist during regulatory agency visits.
Ensure that all storage, handling, and distribution activities for pharmaceutical products—including temperature-sensitive materials—meet required standards.
Monitor cold chain performance, confirm proper functioning of temperature-controlled equipment, and verify data related to transport and storage conditions.
Review and sign off on investigations, quality issues, customer concerns, and associated corrective and preventive actions.
Track quality trends, maintain system performance metrics, and prepare high-level summaries for leadership review.
Work closely with operations, warehousing, and client-facing teams to ensure compliance with good distribution practices and temperature-control requirements.
Evaluate and authorize procedures, qualification protocols, and quality-related agreements.
Ensure employees receive the necessary compliance and quality training.
Support ongoing improvement efforts aimed at refining processes and ensuring strong regulatory alignment.
Bachelor’s degree in a scientific, engineering, or quality-focused field
At least five years of experience in a regulated quality or compliance role within pharma, biotech, or logistics supporting these industries.
Solid understanding of regulatory expectations related to pharmaceutical operations, distribution standards, and handling of sensitive biologic products.
Hands‑on experience managing quality systems and working through audits and regulatory reviews.
Ability to interpret industry regulations and apply them effectively in a logistics or operational setting.
Strong communication skills, leadership capability, and a solutions‑oriented mindset.
Comfortable using quality system software and general office applications.
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