Compliance Manager

Key Responsibilities:

• Monitoring daily shop floor activities and guidance to production team to ensure the quality and compliance.
• Responsible for setting up the plant to meet different regulation requirements including NPRA, MHRA, and USFDA.
• Reviewing the manufacturing processes to identify the scope of improvements/simplifications by coordinating with the R&D department and deriving 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 within defined timelines.
• Ensuring GMP procedures at manufacturing, packing, warehouse, and engineering areas.
• Providing leadership, building/leading teams, and leveraging human capital to improve productivity, eliminate waste, and achieve operational excellence through sustained continuous improvement.
• Conducting training, coordinating with cross-functional departments on training, and evaluating trainees to implement established training practices and procedures.
• Reviewing QMS documents like Change Control, Deviation, Investigation, CAPA, Risk Assessment, SOP, and other relevant documents.
• Facilitating critical investigations and ensuring proper disposition.
• Supporting teams during GMP audits for better compliance.
• Identifying scope for automation/digitalization in processes and developing implementation plans to improve product quality.
• Continuously monitoring regulatory updates and aligning processes by engaging with all stakeholders.

Required Skills:

• 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 startup to established organizations.
• Versatile, meticulous, and resilient, with the ability to multitask and stay positive in high-pressure ambiguous environments while delivering results.
• Proficient in Microsoft Office Suite.
• Excellent leadership, communication, and problem-solving skills.
• Resilience and startup mentality.
• Agile and responsive to new changes and surprises.
• Ability to navigate through uncertainties with confidence in decision-making.
• Recognizing and managing ambiguities in startup and transformation environments.
• Comfortable drawing from team experiences and ideas; encourages and values feedback.
• Courage and confidence to challenge the status quo, lead in idea creation, and break new barriers.
• Actively participating cross-functionally to achieve shared goals.
• Acting with the highest level of integrity and professionalism.

Qualifications:

• Minimum Degree in Pharmacy, Pharmacology, Chemistry, Biotechnology, Biochemistry, or equivalent. Pharmacist qualified, Good Clinical Practice (GCP) certified, Masters, or MBA would be considered a vital asset.
• Minimum 10+ years of related experience in Pharmaceutical Manufacturing from Pharma, Biotechnology, and/or Healthcare industries, with at least 3 years in a leadership role.

Apply now to be part of our exciting journey! If you’re ready to take the next step in your career, we’d love to hear from you! Send your resume to azliza.aziz@perkeso.gov.my