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 Valuable 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

- 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