Job Description

Job Description:

• Position Overview
• The Analytical Project Manager will lead the transfer of outsourced analytical and microbial testing services from an existing contract lab to a new vendor.
• This role ensures continuity of services, regulatory compliance, and integration of the new vendor into quality systems.

Specific Tasks, Duties, and Responsibilities

• Project Management:
• Manage all aspects of the laboratory vendor transition.
• Develop and execute project plans, timelines, and risk mitigation strategies.
• Coordinate with internal stakeholders and external partners.

Vendor Management:

• Serve as the main contact between and the contract analytical organizations.
• Oversee method transfer to ensure testing continuity and data integrity.
• Ensure required approvals are managed through change management procedures.

Analytical & Quality Oversight:

• Manage transfer of validated analytical methods.
• Coordinate parallel sample testing during qualification.
• Ensure analytical documentation is transferred in compliance.
• Review and approve protocols, specifications, and change controls.

Regulatory Compliance:

• Ensure all activities comply with regulatory requirements.
• Support audit readiness at the new vendor site.

Reporting & Communication:

• Provide regular updates on project status, risks, and milestones.
• Maintain project documentation in alignment with quality systems.

Essential Skills and Experience

• Education or Equivalent:
• Bachelor’s degree in Chemistry, Life Sciences, or related field (Master’s a plus).
• Minimum 5 years of experience in quality/analytical sciences.
• Formal project management experience required.

Knowledge/Skills Requirements:

• Experience with method qualification, transfer, contract lab oversight, and GxP regulations.
• Strong project management, communication, and problem-solving skills.
• PMP certification or formal project management training is a plus.

Dimensions of Position

• This is a project-based contract role overseeing the vendor transfer from initiation to completion.

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