Lead Production Pharmacist - Lean & USFDA Compliance

Novugen Pharma (USA) LLC; Nilai; On-site; MYR 180,000 - 240,000; Full time

Job summary

Novugen Pharma (USA) LLC seeks an Associate Manager, Production Pharmacist to lead all production operations in Malaysia, ensuring USFDA and cGMP compliance. You will drive lean initiatives, budget control, and cross-functional collaboration with Quality, Engineering, and Regulatory Affairs.

Ideal candidates hold a Pharmacy degree, a registered license in Malaysia, and 8+ years in pharma/healthcare with regulatory inspections experience.

Qualifications

• Degree in Pharmacy or equivalent; Masters/MBA is a valuable asset.
• Registered Pharmacist with Pharmacy Board Malaysia will be an advantage.
• Minimum 8 years’ related experience in Pharma and Healthcare industries.
• Hands-on experience in regulatory inspections (USFDA, MHRA, TGA, etc.).
• Strong knowledge of cGMP, pharmaceutical production processes, quality systems, and regulatory requirements.
• Scientific rigor, attention to detail / meticulous.
• Courage and confidence to challenge status quo, lead in idea creations.

Responsibilities

• Provide strategic leadership for all manufacturing and product certification activities with full regulatory compliance (USFDA, cGMP).
• Drive continuous improvement for product/process optimization and operational efficiency.
• Develop and implement Lean Manufacturing with Right-First-Time culture.
• Oversee end-to-end production planning and ensure regulatory compliance and timely delivery.
• Establish production performance metrics aligned with objectives and compliance.
• Lead production budget planning and cost control within financial constraints.
• Review and authorize critical production documentation and SOP revisions.
• Drive training and leadership development within the production team.
• Promote cross-functional collaboration with Quality, Engineering, Supply Chain, Regulatory Affairs.
• Serve as pharmaceutical SME ensuring regulatory, quality, safety standards are met.

Skills

Regulatory inspections (USFDA/MHRA/TGA

cGMP knowledge

Quality systems

Leadership

Strategic thinking

Attention to detail

Change management

Education

Degree in Pharmacy

Masters or MBA asset

Job description

Novugen Pharma (USA) LLC seeks an Associate Manager, Production Pharmacist to lead all production operations in Malaysia, ensuring USFDA and cGMP compliance. You will drive lean initiatives, budget control, and cross-functional collaboration with Quality, Engineering, and Regulatory Affairs.

Ideal candidates hold a Pharmacy degree, a registered license in Malaysia, and 8+ years in pharma/healthcare with regulatory inspections experience.