Associate Director, Production

1 week ago

Kampung Baharu Nilai, Negeri Sembilan, Malaysia Novugen Full time

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 eight 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 the 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 Director of Production will lead end-to-end manufacturing operations, ensuring compliance with industry standards and regulatory requirements (e.g., USFDA, GMP, Halal Certifications, etc). This role provides strategic oversight on production planning, process optimization and product quality maintenance, aligning production activities with business goals. The Director of Production will report to the Senior Vice President, Technical Operations and work closely with cross-functional teams (CFTs) such as Quality, Engineering, Supply Chain, R&D and etc.

Job Responsibilities:
  • Develop and implement production department strategies/model in line with best global practices and cGMP's requirements, leveraging on people, technology and resources required and align with the organization's long term business strategies and financial plans.
  • Oversee the day-to-day operations of the manufacturing department, including production planning with CFTs, scheduling, manpower and resource allocation, production cycle time and manufacturing equipment to ensure efficiency, productivity, and profitability targets are consistently met or exceeded.
  • Monitor production to ensure that each batch adheres to manufacturing records, Standard Operating Procedures (SOPs), and product specifications.
  • Continuously drive improvements in quality, reductions in unplanned deviations and right-first-time outcomes.
  • Ensure that all production records (e.g. Batch Manufacturing Records, Batch Packaging Records, SOPs, Change Control, etc), validation protocols and reports are reviewed and approved by authorised parties as part of Quality Management System (QMS) requirements.
  • Review deviation reports and/or non-conformity, ensuring thorough investigations, corrective and preventive actions are implemented within budget and timeframe. Be regulatory ready for inspections and form audit taskforce teams as and when needed.
  • Assume professional duties and responsibilities of a pharmacist in the company. Approve and authorize procurement, storage, manufacture, distribution, and control of drugs.
  • Act as Halal Committee Chair, ensuring compliance with JAKIM/JAIN regulations and Halal certification for registered products. Lead Halal assurance initiatives and compliance practices.
  • Ensure production areas and equipment are qualified, maintained, and adhere to high standards of housekeeping and 5S methodologies.
  • Champion a safe working environment, ensuring all tasks are performed safely and in compliance with HSE standards.
  • Oversee storage and distribution practices for raw materials and finished goods, ensuring adherence to cGMP standards.
  • Implement and advocate for Quality Risk Management practices to maintain and enhance product quality throughout production processes.
  • Support SVP, Technical Operations in budget and forecasting exercises for production department such that overall company's financial and market share objectives are achieved, and internal controls and cost budget management are delivered.
  • Develop contingency plans for business continuity, address complaints and defective materials efficiently. Establish timely communication and escalation protocol to appropriate levels of management.
  • Stay abreast of industry trends, technological advancements, and best practices in manufacturing, and actively seek opportunities to leverage new technologies or methodologies to improve manufacturing processes.
Team Management and Development
  • Develop an innovative production team through hiring, coaching, monitoring and development of training plans for team members.
  • Lead production team to ensure effective execution and integration of production department strategy.
  • Develop an effective reward model to motivate and retain good team members.
  • Champion and be a role model of the Company's values and perform work in alignment with the Code of Conduct.
  • Create a work culture that attracts, motivates, and retains talented employees and develop teams/individuals accordingly.
  • Ensure activities and behaviours comply with the Code of Conduct.
  • Conduct and document regular performance reviews and an annual review as well as regular personal/ career development discussions with direct reports, in line with agreed Performance Management processes.
  • Talent grooming to foster growth and readiness for increased responsibilities.
Stakeholder Management
  • Harness relationship and work collaboratively with manufacturing partners, community and industry bodies relevant to the performance of the Production Department.
  • Proficient in managing cross functional relations at senior level /functional heads and able to work & deliver within teams of different nationality / ethnic groups, across the geographies.
About you
  • Must possess a Degree in Pharmacy, Pharmacology, Chemistry, Biotechnology, Biochemistry, Business Studies, Supply Chain Management or equivalent. Pharmacist qualified, Good Clinical Practice (GCP) certified, Masters, MBA or PHD would be considered a vital asset.
  • Minimum 17 years' related experience in Pharmaceutical Manufacturing from Pharma, FMCG, Biotechnology and / or Healthcare industries, with at least 5 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.
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