Operation QA Supervisor (Shanghai, China)
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About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.
Job Responsibilities
In order to ensure Released product quality in accordance with BI SOP/cGMP/Registered Specification, perform manage complaints\ recalls\counterfeits \deviation management\ CAPA management\ Onsite GMP monitor \release activities under corporate management guideline and cGMP regulation.
Update SOP related to Product quality function according to business needs and regular review to ensure comply with GMP and BI global requirement.
As a Coordinator of project activities related to quality, ensure these activities in accordance with SOP/cGMP/Registered Specification.
Ensure the SOP execution comply with company’s and GMP regulation trough onsite inspection check.
To evaluate batch records and to ensure that the batch records are reviewed before product release delegated by QP; And then release product in SAP system.
As QP delegate, responsible for status change of finished goods and material (after QC usage decision) in SAP.
Assist to manage recall system, coordinate the recall execution, supervise the disposal of recalled goods, execute recall simulation and deliver related report.
Update SOP related to quality complaint, product recall, ACF,.
Assist to manage ACF process, cooperate China Anticounterfeiting Working Group to ACF investigation, deliver relevant report to Management in time.
As LPCO deputy, manage quality complaint system, including collect relevant complaint information, complaint sample management, investigate root cause, review complaint report, deliver conclusion and report archive, CAPA plan review, CAPA follow up, Meanwhile, provide training to plant.
Ensure data integrity and accuracy in Go track system, includes timely input and output, and deliver monthly report.
Organize to ensure Product Quality Review for product.
As local MSO for related quality systems or local key user for related system, responsible for Gap analysis, related Doc. update and training, routine execution and conduct continuous improvement.
As SME in change project to ensure the project compliance with GMP regulation.
Provide timely QA support for deviations root cause investigation, CAPA plan setting and follow up，PQR , Local new product launch .
Requirements:
Bachelor or above, Pharmacy or relevant major
Experience in similar role, minimum of 3 years' MNC experience of QA
Excellent knowledge of GMP
Good specific knowledge relevant to the area/field
Excellent English language skills, both verbal and written
Good organization and planning skills; good time management for emergent issue and priorities, and good at communication and team work spirit.
Customer service focus and understanding of clients’ needs
Confidence, professionalism, and efficiency in managing responsibilities
Adaptability to change, willingness to share and learn
Good analytical and scientific thinking and problem solving skills
Excellent communication, negotiation and persuasion 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 1502 comparable Quality roles across 147 biopharma companies.
Salary context
261 of 1502 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 1502 comparable roles
+ 48 more countries
Seniority mix
731 of 1502 peers have a known seniority level
Therapeutic area mix
3 of 1502 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
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How we calculate "similar"
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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.