Senior Project Manager (Digital)

JR France; Nouméa; Sur place; EUR 45 000 - 65 000; Plein temps

Résumé du poste

A leading pharmaceutical company seeks an experienced project manager for an initial 6-month contract in Nouméa. The role involves overseeing operational readiness for a new product launch, coordinating with multidisciplinary teams, and ensuring compliance with regulatory standards. Ideal candidates will have strong knowledge of cGMP, FDA regulations, and experience in project governance within the pharmaceutical industry.

Qualifications

• Experience with regulatory submission processes and compliance.
• Strong knowledge of pharmaceutical quality standards.
• Project governance and NPI management experience.

Responsabilités

• Lead operational readiness for new product launches.
• Manage regulatory submissions and compliance activities.
• Develop risk mitigation strategies for successful launches.

Connaissances

cGMP

FDA regulations

Cross-functional team collaboration

Risk management

Formation

Bachelor's degree in a related field

Description du poste

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Client:

Blackfield Associates

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

445137634262935142432760

Job Views:

2

Posted:

09.06.2025

Expiry Date:

24.07.2025

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Job Description:

We are looking for an experienced project manager to join a large pharmaceutical company on an initial 6-month contract. This position is responsible for ensuring operational readiness ahead of the commercial launch of a new product. You will oversee and coordinate all New Product Introduction (NPI) efforts, including launch execution, readiness planning, and development of product and process strategies, in collaboration with cross-functional teams at both the site and corporate levels.

Key Responsibilities:

• Lead all operational readiness efforts related to NPI (process and analytical), working with multidisciplinary teams across Manufacturing, Engineering, Quality, MSAT, Supply Chain, and CMC.
• Manage and coordinate regulatory submissions and inspection readiness activities, including Pre-Approval Inspections (PAI).
• Identify potential risks associated with new product launches and develop mitigation strategies to support successful Process Performance Qualification (PPQ) and ensure stable, compliant commercial production.

Technical Expertise Required:

• Strong knowledge of cGMP, FDA regulations, and international pharmaceutical manufacturing and quality standards.
• Experience with Process Analytical Technology (PAT), ASTM standards, and 21st Century cGMP principles.
• Familiarity with ICH Q8, Q9, Q10, and Q11, and their application in a regulated environment.
• Experience with CMC and regulatory submission processes, including NDAs and MAAs.
• Understanding of global regulatory perspectives on Quality by Design (QbD) and their impact on strategy and submissions.
• Broad knowledge of regulatory compliance, validation, and inspection readiness.
• Deep understanding of product development lifecycles, cross-functional teams, and project governance.