Job Description

The Materials Manager has the responsibility for providing quality oversight for Clinical Trial activities. This includes responsibility for the approval of specifications, batch release of raw materials, excipients, and packaging components.

Scope:

Materials Manager (raw materials, excipients, GMP consumables and packaging components) in Product Research and Development (PR&D) Clinical Trial activities

Key Responsibilities:

• Ensure cGMP Compliance and maintain and improve Quality Systems.
• Maintain adequate document control for raw materials, excipients, GMP consumables and packaging components. Review and coordinate, or participate, in local procedure creation, revision, and changes as a SME (subject matter expert). Write and revise procedures and training as required.
• Provide Quality support and oversight for Purchased Material release process, including document review, Usage Decision, material qualification, managing inventory status and re-evaluation.
• Work with business partners to ensure timely release of raw materials, excipients, GMP consumables and packaging components to support business needs.
• Review and approve GMP documents such as specification, change control, investigations/deviation and supplier complaint records.
• Ensure all suppliers of purchased materials (raw materials, excipients, GMP consumables and packaging components) for use in GMP operations are appropriately and timely qualified and approved.
• Maintain Supplier/CP qualification status activities such as supporting supplier/CP audit program, drafting, review and approval of quality agreements and associated documents. Evaluate supplier notification and vendor/CP changes to ensure compliance and adequate support to meet business needs.
• Perform other related duties as assigned.

Basic Qualifications:

• Bachelor's degree in applicable Life Sciences (Examples: Pharmacy, Chemistry, Engineering).
• Three plus years of experience in Quality

Additional Skills/Preferences:

• Materials Science degree preferred
• Previous Quality Assurance Experience including batch release and supplier qualification.
• Previous pharmaceutical manufacturing experience.
• Experience with providing Quality oversight for Collaboration Partners
• Experience with packaging components
• Experience with Material Movement Logistics

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