Sr.Manager - Quality operations

IN04 (FCRS = IN004) Sandoz Private Limited; Telangana; On-site; INR 1,400,000 - 2,600,000; Full time

Job summary

Sandoz Private Limited in India seeks a senior scientific professional to lead nitrosamine risk assessment and related impurity controls across drug substances and products.

The role requires deep knowledge of ICH M7, mutagenic impurities, and regulatory expectations, with proven ability to manage complex projects and collaborate with global teams. English fluency and strong scientific writing are essential.

Qualifications

• Minimum 6 years of relevant pharma industry experience; or minimum 3 years with a PhD.
• Proven experience in mutagenic impurities and/or nitrosamines risk assessment.
• Strong knowledge of ICH M7 and regulatory expectations.

Responsibilities

• Lead nitrosamine risk assessments and mitigation strategies.
• Manage multiple projects with timely delivery.
• Collaborate with cross-functional teams across sites.
• Ensure compliance with SOPs and regulatory guidelines.

Skills

Analytical thinking

Problem solving

Fluent English

Scientific writing

Education

PhD preferred

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.

Skills

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

Our Purpose here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!