Associate Manager, Production

Novugen; Nilai; On-site; MYR 60,000 - 80,000; Full time

Job summary

Novugen is seeking an Associate Manager for Production to oversee operations in its USFDA-approved facilities. The role demands strong leadership and technical expertise to ensure compliance with GMP and quality standards while driving process improvements in pharmaceutical manufacturing.

Qualifications

• 5 to 7 years of experience in Pharmaceutical Manufacturing.
• At least 3 years in a leadership role.
• Hands-on experience in regulatory inspections like USFDA.

Responsibilities

• Oversee production and certification activities ensuring GMP compliance.
• Manage product development focusing on quality improvement.
• Coordinate training programs and monitor daily production operations.

Skills

Attention to detail

Problem-solving

Leadership

Integrity

Adaptability

Education

Degree in Pharmacy

Master's or MBA

Tools

Microsoft Office Suite

Job description

About us

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 is responsible for overseeing production operations, ensuring compliance with GMP and regulatory standards, managing product development, quality improvement, and process validation. This role involves performance tracking, troubleshooting, audit compliance, SOP management, cross-functional coordination, and leading training programs, while ensuring safety and quality across production activities.

Key Responsibilities: -

• Oversee production and certification activities, ensuring compliance with Good Manufacturing Practice (GMP) and local regulatory requirements.
• Manage product development activities, focusing on product quality improvement, process validation, equipment qualification, and troubleshooting.
• Contribute to implementing lean transformation initiatives such as right-first-time quality, cycle time reduction, waste elimination, increased capacity, and enhanced efficiency
• Monitor and support daily production operations, ensuring proper management of materials, processes, and facilities to meet production schedules and regulatory standards.
• Track production performance, analyze reports, and resolve issues to ensure production targets and productivity goals are met.
• Assist in capacity and budget planning, providing data-driven recommendations to production management and senior leadership.
• Review and ensure accuracy of quality documentation, including VMP, SMF, PQR, PPQ protocols, risk assessments, deviations, CAPA, and change control.
• Ensure compliance with regulatory requirements during audits, implementing corrective and preventive actions (CAPA) to address non-conformance issues.
• Review and update Standard Operating Procedures (SOPs) related to production activities, ensuring they are followed by all team members.
• Coordinate and implement training programs with cross-functional departments, ensuring staff are trained according to established procedures.
• Review and approve Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for compliance before submission to Quality Assurance.
• Facilitate effective communication with cross-functional teams to ensure all manufacturing activities meet quality, safety, and compliance standards.
• 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.
• Any other ad hoc tasks assigned by the management

About you

• Must possess a Degree in Pharmacy or equivalent. Having Masters or MBA would be considered a vital asset.
• 5 to 7 years of related experience in Pharmaceutical Manufacturing or, Biotechnology and / or Healthcare industries, with at least 3 years in a leadership role
• Hands-on experience in regulatory inspections (e.g., USFDA, MHRA, TGA, etc.).
• Strong knowledge of cGMP, pharmaceutical production processes, quality systems, and regulatory requirements.
• Delivers accurate, high-quality work with strong attention to detail in production and quality processes.
• Experienced in leading, coaching, and developing teams to improve performance and achieve results.
• Strong mechanical aptitude, problem-solving and cost management mindset.
• High level of integrity and professionalism.
• Adaptable to changing priorities and able to manage multiple stakeholders effectively.
• Strong intrapreneurial skills and mindset from start up to established organization
• Versatile, meticulous and resilient, ability to multitask and stay positive in high-pressure ambiguous environments and work towards delivering results
• Proficient in Microsoft Office Suite
• Proficient in using software / tools relevant to pharmaceutical or healthcare industry etc
• For plant administration, must be willing to work in Bandar Enstek, Negeri Sembilan.