Assistant Manager(QAContract Manufacturing Manager – Pharmaceuticals)

JOB Position: Assistant Manager (QA/Contract Manufacturing Manager Pharmaceuticals)

Job Summary

The Contract Manufacturing Manager in the pharmaceutical sector is responsible for overseeing outsourced manufacturing operations with Contract Manufacturing Organizations (CMOs). The role ensures that all products are manufactured in compliance with global regulatory standards such as GMP while meeting quality cost and delivery targets. This position plays a critical role in maintaining supply continuity and regulatory compliance.

Key Responsibilities

CMO (Contract Manufacturing Organization) Management

• Identify evaluate and onboard CMOs for drug product and/or API manufacturing
  
• Act as the primary liaison between the company and CMOs
  
• Manage technical operational and commercial relationships
  

Regulatory & Compliance

• Ensure compliance with global regulatory standards such as US FDA EMA and WHO guidelines
  
• Ensure adherence to Good Manufacturing Practice (GMP) and data integrity requirements
  
• Support regulatory submissions audits and inspections
  

Quality Assurance

• Collaborate with QA teams to ensure product quality and compliance
  
• Review batch records deviations change controls and CAPAs
  
• Participate in internal and external audits and ensure timely closure of observations
  

Production & Supply Planning

• Coordinate production planning with CMOs based on demand forecasts
  
• Ensure timely manufacturing packaging and delivery of products
  
• Monitor inventory levels and avoid stock-outs or overproduction
  

Technology Transfer

• Lead and support process and analytical technology transfer to CMOs
  
• Ensure smooth scale-up from R&D to commercial manufacturing
  
• Coordinate validation activities (process validation cleaning validation etc.)
  

Cost & Contract Management

• Negotiate contracts pricing and service agreements with CMOs
  
• Monitor manufacturing costs and identify cost-saving opportunities
  
• Track and report KPIs (OTIF batch success rate deviations etc.)
  

Risk Management

• Identify and mitigate risks related to supply quality and compliance
  
• Develop contingency plans and dual sourcing strategies
  
• Ensure business continuity planning
  

Qualifications

Education

• Bachelors or masters degree in pharmacy
  

Experience

• 512 years in pharmaceutical manufacturing or supply chain
  

Key Competencies

• Regulatory compliance mindset
  
• Quality and patient safety focus
  
• Cross-functional leadership
  
• Negotiation and influencing skills