About this opportunity
Lead the site quality organization to ensure regulatory compliance, product quality, and operational excellence across all manufacturing activities, in alignment with cGMP, ISO standards, and Novartis quality policies.
Core ResponsibilitiesQuality Leadership & GovernanceLead and structure the site Quality organization to support all manufacturing operationsEstablish and maintain an effective Quality Management System (QMS)Drive quality governance, including Management Review and performance monitoringOwn Manufacturing Quality Systems within the SM platformRegulatory Compliance & Inspection ReadinessEnsure full compliance across all products with regulatory and corporate quality standardsMaintain continuous inspection readiness and audit complianceManage regulatory registrations and authority interactionsLead internal/external audits and GxP inspection activitiesProduct Quality & ReleaseEnsure quality across all manufacturing streams (solid, ophthalmic, aseptic)Approve batch release ensuring compliance with filings and specificationsApprove Product Quality Reviews (PQR/APQR)Act as Qualified Person / Technical Responsible PersonQuality Systems & Risk ManagementLead risk-based quality management and continuous improvementEnsure effective management of deviations, OOS/OOX, complaints, and recallsAct as escalation point for critical quality issuesMonitor Key Quality Indicators (KQIs)GxP Oversight & Change ManagementProvide oversight across all GxP processesEnsure compliant and timely handling of change controlsEnsure data integrity, eCompliance, and regulatory adherenceQualification, Validation & EquipmentEnsure facilities, utilities, and equipment are qualified and maintainedEnsure all products undergo appropriate process validationLeadership & CultureBuild and develop high-performing Quality teamsDrive talent management, succession planning, and capability buildingFoster a culture aligned with Novartis values: Inspired, Curious, UnbossedEnsure workforce training and GMP qualification complianceHSE & Business ContinuityPromote strong Safety & Quality cultureEnsure business continuity and crisis management readinessParticipate in site emergency management as requiredKey Accountabilities (China GMP Focus)Ensure effective operation of Quality Assurance & Quality Control systemsGuarantee data integrity, traceability, and regulatory complianceApprove and oversee: Batch records and releaseDeviations, change controls, and investigationsValidation, qualification, and technical documentationEnsure effective: Supplier qualificationStability programsComplaints and recall handlingLead periodic quality risk reviews and continuous improvementIdeal Candidate ProfileExperience12–15+ years in pharmaceutical QA/QC and/or manufacturingStrong experience in GMP, aseptic and solid dosage environmentsProven leadership in operations, quality systems, and cross-functional collaborationEducationDegree in Pharmacy, Chemistry, Engineering, Biotechnology or equivalentLanguagesFluent English; local language preferredKey CompetenciesStrategic leadership & change managementDeep expertise in GxP quality systemsStrong stakeholder engagement and regulatory interfaceRisk management & decision-making capabilityCommunication and influencing skills
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 644 comparable Quality roles across 85 biopharma companies.
Salary context
110 of 644 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 644 comparable roles
+ 39 more countries
Seniority mix
309 of 644 peers have a known seniority level
Therapeutic area mix
0 of 644 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
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.
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.