Sr.Manager - Quality operations
About this opportunity
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
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 330 comparable Manager Quality roles across 80 biopharma companies.
Salary context
58 of 330 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 330 comparable roles
+ 32 more countries
Seniority mix
330 of 330 peers have a known seniority level
Therapeutic area mix
1 of 330 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.