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

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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 Positive 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 prospects
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
Bachelor’s or master’s degree in pharmacy,

Experience
5–12 years in pharmaceutical manufacturing or supply chain

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

📌 Assistant Manager Qa/contract Manufacturing Manager – Pharmaceuticals Mumbai
🏢 Talent Linked Consultancy
📍 Mumbai