Senior Associate Manager, Production Compliance

About us Novugen is a wholly owned subsidiary company of a UAE based group, SciTech International. With over 30 years of experience in the healthcare industry, the company is equipped with vast and successful experience of venturing into strategic healthcare businesses and development of world-class healthcare facilities around the globe. Novugen’s passion for science and bold global strategy prepared us to respond to challenges of bringing hard-to-source and technology-intensive pharmaceutical products to the market. Novugen specializes in niche and difficult to formulate generics for all therapeutic areas of pharmaceutical and oncology drug products while meeting stringent global quality standards. With vertical integration from Active Pharmaceutical Ingredients (API) to Finished Products R&D and manufacturing based in Malaysia, it gives us greater control over the supply chain. Our pharmaceutical and oncology manufacturing facilities in Bandar Enstek, Negeri Sembilan are the first in Malaysia and the only in Southeast Asia with approval from USFDA. The people behind Novugen are professionals coming from diverse backgrounds and nationalities from all over the world, working together to achieve one common goal. We are committed to ensuring early access to high-quality products that lack robust generic alternatives due to their complexity. Our vision is to be the largest and fastest growing pharmaceutical company in Southeast Asia by 2025, competing in global markets. About the role The Senior 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 Senior Associate Manager, Production Compliance will report to the Senior Vice President, Technical Operations and work 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/ lead team and leverage human capital for improving their productivity, 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. Team Management and Development • Develop an innovative production team through hiring, coaching, monitoring and development of training plans for team members • Lead Compliance team to ensure all time audit readiness. • Develop an effective reward model to motivate and retain good team members • 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. 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. • Resilience and start-up mentality • Agile and respond quickly to new changes and surprises • Navigate through uncertainties with good degree of confidence in making decisions • Recognize and manage ambiguities in start-up and transformation environment • Comfortable drawing from team’s experiences and ideas, encourages and values feedback • Courage and confidence to challenge status quo, lead in idea creations and break new barriers • Stay invested and participate actively cross functionally to achieve shared goals • Acting with highest level of integrity and professionalism