Compliance Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Job Responsibilities:

Research and address issues using problem-solving methodology, detailing in accordance with ALCOA principles and tracking metrics related to quality and compliance activities.

Lead quality and compliance processes, ensuring their successful execution and completion.

Lead quality audits team in support of GMP regulatory and client audits. Point of contact for regulatory audit support and audit observation responses.

Independently perform internal audits in support of the site goals.

Lead and/or participate in process improvement initiatives.

Collaborate with representatives from other departments to maintain quality and timelines for compliance activities, such as client audits and procedural documents.

Develop complex support materials, presentations, and tools to support the department's remit and strategies.

Provide training and mentorship to junior team members.

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