New Product Introduction Senior Manager

Position Summary

1. Launch new technology, products, and technical transfers.
2. Oversee validation processes, including lifecycle management and continuous improvement.
3. Manage packaging engineering, including specifications and artwork for new and existing packaging materials.

Regulatory Compliance Responsibilities

1. Good Manufacturing Practices (GxP):

   • Adhere to cGxP and local regulatory requirements.
   • Report incidents and deviations.
   • Propose solutions to enhance compliance.

2. Safety, Health, and Environment (EH&S) Performance:

   • Follow EH&S procedures.
   • Use personal protective equipment correctly.
   • Report safety incidents and propose improvements.
   • Promote and support EH&S campaigns.

Major Job Duties and Responsibilities

Product Transfer / Introduction:

• Ensure timely and complete product launches.
• Oversee NPI projects and manage stakeholders.
• Collaborate with leadership to set technology roadmaps.
• Develop NPI team through performance and career conversations.

Validation Processes and Lifecycle Management:

• Ensure validation processes align with global procedures and local regulations.
• Maintain the Validation Master Plan.
• Lead or support complex failure investigations.

Packaging Engineering:

• Implement packaging solutions for local market requirements.
• Manage materials and introduce packaging innovations.

Inspection Readiness and Execution:

• Provide technical support for regulatory audits.
• Prepare and deliver presentations for inspections.

Organizational Leadership:

• Manage team according to site and technical operations priorities.
• Motivate the team to drive performance through innovation and change.
• Provide leadership and development opportunities.
• Handle personnel management, including hiring and terminations.
• Monitor and improve site technical operations KPIs.

Qualifications

Education and Experience (Essential)

1. University degree in Engineering or Science
2. Project management experience

Education and Experience (Desirable)

1. Master's degree or equivalent
2. Experience with the FPX (Flawless Project Execution) program

Knowledge, Qualification, and Skills

1. Experience in formulation, primary packaging, and secondary packaging (desirable)
2. API manufacturing for small/large molecules (desirable)
3. Quality assurance and regulatory knowledge
4. Strong ability to operate in diverse and ambiguous environments
5. Strategic thinking skills
6. Ability to identify win-win situations
7. Fluency in English
8. Fluency in the local language (desirable)

Core Competencies

1. Integrity and adherence to credo values
2. Collaboration and teamwork
3. Customer focus
4. Compliance with EHS rules and procedures
5. Technical understanding
6. Logical and strategic action-taking
7. Ability to influence others and make a difference
8. Flexibility in business execution within diverse and ambiguous environments
9. Clear and concise communication

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