Sr.Manager - Quality operations

Sandoz; Telangana; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Sandoz is seeking a seasoned scientist to lead nitrosamine risk assessment and control activities across drug substances and products. You will serve as a SME for N-nitrosamines and mutagenic impurities, guiding risk assessment, mitigation strategies, and regulatory alignment.

The role requires strong scientific writing, cross-functional collaboration, and hands-on use of literature databases and analytical tools.

Qualifications

• Requires strong knowledge of ICH M7 and regulatory expectations for mutagenic impurities and nitrosamines.
• Experience performing impurity risk assessments and developing control strategies.
• Familiarity with API synthesis, impurity formation pathways, and pharma manufacturing processes.
• Excellent scientific writing and documentation skills.

Responsibilities

• Lead nitrosamine risk assessment activities and develop mitigation strategies.
• Perform complex impurity risk assessments and support remediation plans.
• Ensure compliance with regulatory requirements and quality standards.
• Collaborate with international cross-functional teams and communicate findings clearly.

Skills

Mutagenic impurities

N-nitrosamines

Risk assessment

Analytical problem-solving

Scientific writing

Project management

Cross-functional collaboration

English fluency

Education

PhD in relevant field

Tools

SciFinder

Reaxys

ChemDraw

Job description

Job Description Summary

Lead and manage scientific and operational project activities related to nitrosamine risk assessment and control, ensuring alignment with regulatory requirements, scientific standards, and business objectives and serve as a subject matter expert for N-Nitrosamines, mutagenic impurities, and other related impurity assessments across drug substances and drug products.

Job Description

Major accountabilities

Scientific & Technical Expertise

• Apply advanced scientific knowledge in mutagenic impurities and N-nitrosamines.
• Perform complex risk assessments and develop mitigation/remediation strategies.
• Troubleshoot scientific challenges using analytical and problem-solving skills.
• Conduct scientific literature and information searches.
• Promote knowledge sharing within the organization.

Execution & Delivery

• Independently manage and complete projects within agreed timelines and quality standards.
• Handle multiple activities simultaneously.
• Demonstrate initiative, accountability, and innovative thinking.
• Work proactively with minimal supervision.

Compliance

• Ensure all activities comply with regulatory requirements.
• Follow applicable quality standards, SOPs, and guidelines.

Collaboration & Communication

• Work in alignment with the Sandoz culture and values.
• Collaborate effectively with international cross-functional teams.
• Build and maintain strong stakeholder relationships.
• Communicate scientific findings clearly and effectively.

Minimum Requirements

Experience

• Minimum 6 years of relevant pharmaceutical industry experience; or
• Minimum 3 years of relevant experience with a PhD.
• Proven experience in assessing mutagenic impurities and/or nitrosamines within a pharmaceutical environment.

Technical Competencies

• Strong understanding of ICH M7 principles and regulatory expectations related to mutagenic impurities and nitrosamines.
• Experience performing impurity risk assessments and developing control strategies.
• Familiarity with pharmaceutical manufacturing processes, API synthesis, and impurity formation pathways.
• Strong scientific writing and documentation skills.
• Technical expertise in Organic Chemistry, API synthesis, and pharmaceutical manufacturing processes.
• Experience in nitrosamine, mutagenic impurity, and quality risk assessments.
• Strong regulatory compliance knowledge (ICH M7, FDA, EMA, MHRA requirements).
• Excellent scientific writing, analytical thinking, and data interpretation skills.
• Effective communication, project management, and cross-functional collaboration capabilities.
• Hands on experience using Sci finder, Reaxys, Chem draw and other literature searching tools

Professional Skills

• Excellent analytical thinking, problem-solving, and decision-making abilities.
• Ability to work independently and manage multiple priorities effectively.
• Strong stakeholder management and communication skills.
• Demonstrated success working within global, cross-functional teams.
• Fluent in English, both written and spoken.

Skills Desired

Continued Learning, Dealing With Ambiguity, Employee Performance Evaluations, Gmp Procedures, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence