About this opportunity
Ensure the quality of the finished products that are imported and distributed by Country Organization is complied with both a) Korea Pharmaceutical Law and the related regulation and b) Novartis Corporate Quality Manual and Policies (Quality manual and the relevant SOP) including cGxP requirements
Major AccountabilitiesAccountable for product compliance to local/international regulations as well as Novar tis Corporate Quality Policy.Ensure that all drug products are released to the market in a timely manner in accordance with the registered specifications and with local/international regulations.Manage the effective Change Control process.Manages the documentations and archiving of QA data and records to be compliant with local regulations, Novartis Corporate guideline and GMP requirements.Conducts the review of the accordance between the analytical testing specifications/methods and registered product license.Performs management of analytical method transfer and analytical testing documents transfer complied with both Novartis QM/QD and relevant SOPs under pharmaceutical law.Manage external inspections, complaints, deviations, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures and implement each CAPA timely.Manage technical complaints including reporting to appropriate investigation sites, managing investigation processes, and ensuring that appropriate corrective actions are taken.Identifies and reports any quality or compliance concerns and implementation of immediate corrective action as requiredEnsures the readiness for escalation including prompt decision and actions of recall / Market action.Report monthly Key Quality Indicators (KQIs) and monitor them and assure that gaps are addressed appropriately in order to mitigate risk.Establish a good working relationship with the Supply Chain Management (SCM) / RA departments as well as External Supply Organization (ESO) allowing to keep QA oversight on all partners (e.g. third-party activities).Ensures that returned and defective products are managed and disposed in accordance with GMP requirements.Ensure reporting and follow up of all spontaneous adverse events (AE) and technical complaints for all Novartis Corporate products according to respective SOP. Key Performance Indicators (KPIs)Local GMP Quality System in place and continuously updated, as requiredGMP related risks proactively identified and effectively mitigatedThe number and severity of GMP issues identified during internal and external auditsNo regulatory problem/action due to inefficient local Change Control procedureTraining conducted according to program EducationDegree in Life Sciences or related fields (Pharmacy preferred)LanguageGood command in English (speaking and writing)ExperienceMin. 3 year experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, production or a directly related areaStrong Interpersonal skillsStrong Project Management and leadership skillsAbility to work under pressure and matrix organizationHighly proficient in negotiation skillsHighly effective in influencing others
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 1008 comparable Quality roles across 131 biopharma companies.
Salary context
193 of 1008 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 1008 comparable roles
+ 42 more countries
Seniority mix
498 of 1008 peers have a known seniority level
Therapeutic area mix
2 of 1008 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.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
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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.