Commercial Quality Specialist (Seoul, Korea, Republic of, Busan)
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THE POSITION
Support to the establishment, continuous improvement and maintenance of the Quality Management System at Boehringer Ingelheim Korea by ensuring that all external (e.g. Good Distribution Practice, Good Storage Practice, Korean regulation) and internal Boehringer Ingelheim requirements are implemented at Boehringer Ingelheim Korea.
Tasks & responsibilities
Support Quality Management System of Boehringer Ingelheim Korea Human Pharma and Animal Health.
- Support the management of local quality operation/activities to ensure it is compliant to applicable regulatory
and Boehringer Ingelheim requirements.
- Ensuring the set up and maintenance of a document management system for local SOPs/ Working Instructions.
- Maintaining a library of all the relevant regulations and guidelines related to commercial product supply and
Distribution.
- Supporting Quality System, which includes Deviation, Complaint, Change Control, Risk, CAPA Management.
Support Audit Management, which includes self-inspections, internal audits and authority inspections.
- Ensuring regular self- inspections at Korea to drive the continuous improvement program and to ensure
readiness for Corporate or Korean authority inspections.
- Managing audits by Corporate or inspections by local Authorities in respect to quality compliance.
- Ensuring adequate CAPA plans are established and tracked for audit/inspection completion.
Support external 3rd party Management.
- Ensuring quality and regulatory compliance of products/ services which are out-sourced to external parties.
- Supporting quality audits at local suppliers and external parties (qualification and regular audit).
- Acting as first escalation to resolve quality issues from external parties.
Release commercial batch as back up of authorized batch releasing person for Boehringer Ingelheim Korea Human Pharma.
- Supporting Batch disposition (release/ reject) for distribution of human pharma product in accordance with
Korean regulation as a back up of authorized batch releasing person.
- Supporting product launch which includes analytical method transfer and preparation of quality documents.
- Ensuring correct handling and storage of market returns, promotional and retention/reserve samples.
Requirements
Korea Pharmacist License.
Fluent Korean language and English communication skills are required.
Minium 2 years of quality or regulatory function experience are preferred.
Domestic business traveling.
Attitude to d evelops and maintains constructive relationships internally and externally .
Mindset for continuous improvement .
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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.