Associate Manager, Production Pharmacist

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 is a wholly owned subsidiary of SciTech International, a UAE-based group with over 30 years of experience in the healthcare industry. We specialize in venturing into strategic healthcare businesses and developing world-class healthcare facilities across the globe. With operations in multiple countries across continents, our global presence and expertise empower us to meet the complex challenges of delivering hard-to-source, technology-intensive pharmaceutical products to market.

Our manufacturing facilities in Bandar Enstek, Negeri Sembilan, are the first USFDA-approved pharmaceutical manufacturing facilities in Malaysia and Southeast Asia. We are also the first pharmaceutical company in the region to be vertically integrated from R&D to manufacturing, giving us greater control over the supply chain and reflecting our commitment to meeting a wide range of stringent regulatory standards.

At Novugen, we are united by a shared vision, with a team of talented individuals from diverse backgrounds and nationalities working together towards one common goal. We are driven by a passion for science and innovation, striving to accelerate the launch of pharmaceuticals that lack robust generic alternatives due to their complexity. Our continued investment in R&D and dedication to excellence aim to provide early access to affordable, high-quality medicines, impacting lives across the world.

Together, we are shaping the future of healthcare and changing lives everywhere.

About the Role

The Associate Manager, Production Pharmacist leads and oversees all production operations, ensuring compliance with USFDA and GMP standards. Key responsibilities include driving continuous improvement, lean manufacturing, strategic planning, budget control, team development, documentation oversight, cross-functional collaboration, and upholding safety, quality, and ethical pharmaceutical practices.

Key Responsibilities:

• Provide strategic leadership and direction for all manufacturing and product certification activities within the facility, ensuring full compliance with USFDA regulations and current Good Manufacturing Practices (cGMP).
• Spearhead continuous improvement initiatives focused on product and process optimization, quality enhancement, and operational efficiency.
• Develop and implement a comprehensive Lean Manufacturing strategy, embedding a Right-First-Time culture and driving consistent operational excellence across all production units.
• Oversee end-to-end production planning and execution to ensure adherence to regulatory requirements, timely delivery of finished goods, and fulfillment of market demand.
• Establish, monitor, and evaluate production performance metrics, including Strategic and Key Result Areas (SRAs/KRAs), to ensure alignment with organizational objectives and compliance standards.
• Lead production budget planning and cost control initiatives; optimize resource utilization and ensure efficient operations within defined financial and time constraints.
• Review and authorize all critical production documentation; ensure timely review and revision of Standard Operating Procedures (SOPs) to uphold regulatory compliance and operational discipline.
• Drive a structured training and development framework focused on enhancing technical competencies and leadership capabilities within the production team.
• Promote cross-functional collaboration with Quality, Engineering, Supply Chain, and Regulatory Affairs to ensure seamless operational alignment and support strategic business goals.
• Serve as the pharmaceutical subject matter expert, ensuring all production activities align with applicable regulatory, quality, and safety standards while upholding ethical and professional responsibilities as a registered Pharmacist.
• Advocate and enforce a robust safety culture by ensuring strict compliance with workplace safety regulations and best practices.
• Lead technical inputs for inspections (regulatory, government authority and customers).
• Efficiently represent the production function at all cross-department and leadership meetings.

About You

• Possess a Degree in Pharmacy or equivalent. A Masters or MBA would be considered a vital asset.
• Registered Pharmacist with Pharmacy Board Malaysia will be an advantage.
• Minimum 8 years’ related experience from Pharma, and Healthcare industries.
• Hands-on experience in regulatory inspections (e.g., USFDA, MHRA, TGA, etc.).
• Strong knowledge of cGMP, pharmaceutical production processes, quality systems, and regulatory requirements.
• Scientific rigor, attention to detail / meticulous.
• Recognize and manage ambiguities in start-up and transformation environment.
• Courage and confidence to challenge status quo, lead in idea creations and break new barriers.