Senior Associate Manager, Production Compliance

Novugen; Nilai; On-site; MYR 80,000 - 120,000; Full time

Job summary

A pharmaceutical company based in Malaysia is seeking a Senior Associate Manager for Production Compliance. This role involves leading manufacturing activities, ensuring compliance with regulatory standards such as USFDA and GMP. The ideal candidate will have a significant background in pharmaceutical manufacturing with at least ten years of experience, including three in leadership positions. Strong leadership and regulatory compliance knowledge are essential for success in this role.

Qualifications

• Minimum 10 years of experience in Pharmaceutical Manufacturing.
• At least 3 years in a leadership role.
• Certified in Good Clinical Practice (GCP) and/or hold a Master's or MBA preferred.

Responsibilities

• Lead end-to-end manufacturing activities, ensuring compliance with industry standards.
• Monitor daily shop floor activities and provide guidance.
• Conduct training and evaluation for trainees.

Skills

Leadership

Regulatory compliance

GMP knowledge

Problem-solving

Communication

Multitasking

Education

Degree in Pharmacy, Pharmacology, Chemistry, Biotechnology, or Biochemistry

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

TheSenior Associate Manager, Production Compliance will lead end-to-end manufacturing activities, ensuring compliance with industry standards and regulatory requirements (e.g., USFDA, GMP, Halal Certifications, etc). The role reports to the Senior Vice President, Technical Operations and works closely with cross-functional teams (CFTs) such as Quality, Production, Engineering, Supply Chain, R&D etc.

Key Responsibilities

• Monitoring daily shop floor activities and guidance to production team to ensure the quality and compliance.
• Responsible to setting up the plant to meet different regulation requirement including NPRA, MHRA and USFDA.
• Responsible to review the manufacturing processes for identifying the scope of improvements / simplifications by coordinating with R&D department and deriving the execution plans.
• Overseeing project activities from conceptualization to execution including technical specifications, stage inspections, progress monitoring and site management.
• Coordinating with Regulatory in variation filings and facilitating the changes implementation in the defined timelines.
• To ensure GMP procedure at manufacturing, packing, warehouse and Engineering areas.
• Provide leadership, build and lead a team, driving productivity, improving waste elimination and achieving operational excellence through sustained continuous improvement.
• Responsible to conduct training, coordination with cross functional department on training and evaluation of trainees and to implement established training practices and procedures.
• Responsible to review the QMS documents like Change control, deviation, Investigation, CAPA, Risk Assessment, SOP and other relevant documents.
• Facilitating the critical investigations and ensure proper disposition.
• Hand holding the teams during the GMP audits for better compliance.
• Identifying the scope for automation / digitalization in processes and implementation plans to improve the quality of the product.
• Continuous check on the regulatory updates and aligning the processes by engaging with all stakeholders.

About you

• Must possess a Degree in Pharmacy, Pharmacology, Chemistry, Biotechnology, Biochemistry or equivalent. Pharmacist qualified, Good Clinical Practice (GCP) certified, Masters, MBA would be considered a vital asset.
• Minimum 10 years’ related experience in Pharmaceutical Manufacturing from Pharma, Biotechnology and / or Healthcare industries, with at least 3 years in a leadership role.
• Experience in working with OSD and knowledge on other dosage forms shall be an advantage
• Proven track record in managing complex production operations within a regulated environment
• Strong knowledge of GMP, regulatory compliance, and quality control practices
• Experience with Lean Six Sigma, or similar process improvement methodologies is highly preferred
• 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
• Excellent leadership, communication, and problem-solving skills.