Lifecycle Management Specialist

Role Overview

We are seeking a Lifecycle Management Specialist Consultant to support a large molecule drug product primary container team. This role focuses on ensuring the quality, compliance, and lifecycle management of primary packaging materials used in drug product filling operations.

The position is centered on managing supplier-driven changes, maintaining robust documentation, and supporting the technical and regulatory control of primary container systems. It is well suited to a detail-oriented professional with strong knowledge of primary packaging materials, parenteral production environments, and cross-functional change management.

Key Responsibilities

Change Control Management

Lead and manage change controls triggered by supplier change notifications and compendial updates. This includes preparing the required documentation, coordinating internal review and approval activities, and ensuring that stakeholder needs are addressed across QA, QC, MSAT, and DDS functions.

CAPA and Nonconformance Management

Manage nonconformities, including root cause analysis investigations and CAPA plans. The role requires a structured approach to issue resolution, risk assessment, and implementation of effective corrective and preventive actions.

Specification Review

Create, review, and update internal primary packaging specifications to ensure alignment with quality standards, technical requirements, and applicable procedures.

Technical Documentation

Prepare test protocols and reports related to functional, physio-chemical, and mechanical testing of primary packaging materials. Perform statistical analysis of data using appropriate tools such as Minitab to support technical evaluation and decision-making.

Regulatory Support

Support the preparation of regulatory documentation related to quality and compliance topics, including items such as Nitrosamine statements and Container Closure System documentation for Module 3.2.P.7.

Required Profile

The ideal candidate has a background in pharmaceutical operations or manufacturing, with specific knowledge of primary packaging materials and parenteral production environments. Strong analytical skills, project management capability, and experience handling change controls in a regulated setting are essential.

The role also requires fluency in English and the ability to work effectively across technical and quality functions.

System and Tool Knowledge

Experience with the following systems and tools is important for this role:

• Comet software.

• Minitab.

• PowerPoint.

• Excel.

• SAP.

Suitable Candidate Profile

This role is best suited to professionals who have experience in pharmaceutical packaging, manufacturing support, MSAT, quality operations, or technical lifecycle management. Candidates with a strong understanding of supplier change management, packaging specifications, technical reporting, and regulatory documentation will be particularly well aligned.

Summary

This is a highly technical and quality-focused lifecycle management role supporting primary container materials for large molecule drug product operations. The consultant will play a key role in maintaining compliance, managing change, supporting investigations, and ensuring technical and regulatory robustness across the packaging lifecycle.