Manager / Sr. Manager (Contract Manufacturing & Quality Compliance)

Job Description Manager / Sr. Manager (Contract Manufacturing & Quality Compliance)

Location:

Role Overview

We are seeking an experienced and proactive professional to manage and coordinate production activities at contract manufacturing sites. The ideal candidate will have strong expertise in production planning, quality systems, regulatory compliance, and cross-functional collaboration to ensure timely supply of high-quality products in alignment with business objectives and global regulatory expectations.

Key Responsibilities

Production & Planning

• Manage and oversee production planning at contract manufacturing sites to achieve productivity and supply targets.
  
• Collaborate with internal teams and CMOs (Contract Manufacturing Organizations) for on-time execution of manufacturing schedules.
  

Quality & Compliance

• Establish, monitor, and enhance quality systems at contract sites ensuring adherence to cGMP and international regulatory requirements.
  
• Promote a culture of quality and compliance across partner sites, ensuring readiness for export market audits.
  
• Review batch manufacturing records and ensure product quality in line with cGMP guidelines.
  
• Oversee shop-floor compliance, reviewing incidents, deviations, and change controls for timely closure.
  
• Drive resolution of quality audit observations, market complaints, and CAPA implementation.
  
• Ensure robust quality systems that deliver zero critical/major complaints.
  

Technology Transfer & New Products

• Coordinate with technology transfer teams for new product introductions and product transfers to CMOs.
  
• Support smooth and timely execution of technology transfer activities to meet market and business requirements.
  

Training & Capability Development

• Conduct training programs to upskill site teams and ensure preparedness for regulatory inspections.
  

Process Improvement & Cost Optimization

• Identify and implement continuous improvement opportunities for efficiency, process optimization, and cost reduction at CMO sites.
  

Vendor & Market Engagement

• Engage with vendors, industry stakeholders, and potential third-party manufacturers to strengthen the vendor network and ensure future scalability.
  

Desired Candidate Profile

• Education:

  B.Pharm / M.Pharm / M.Sc. in Pharmaceutical Sciences or related discipline.

• Experience:

  8 - 10 years in pharmaceutical manufacturing, quality assurance, or contract manufacturing operations.
• Strong knowledge of cGMP and global regulatory guidelines (USFDA, EMA, MHRA, etc.).
  
• Proven experience in managing contract manufacturing sites and handling regulatory audits.
  
• Exposure to technology transfer, process improvement, and vendor management.
  
• Demonstrated leadership, communication, and problem-solving abilities.
  

Key Competencies

• Excellent knowledge of pharmaceutical production and quality systems.
  
• Strong project management and coordination skills.
  
• Ability to manage multiple stakeholders and vendors effectively.
  
• Analytical mindset with a balance of compliance and cost optimization.
  
• Commitment to fostering a strong culture of quality and compliance.