Quality Systems and Compliance Manager

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.

Requirements

• 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.