Quality Control Manager - Assays

Quality Control Manager – Assays

The Quality Control Manager - Assays will build and own the measurement and control system for assay-critical raw materials, intermediates, assembled strips and finished diagnostic products manufactured internally and through vendors/contract manufacturers.

The role is accountable for translating assay performance and product risk into practical specifications, QC methods, sampling plans, release evidence, vendor QC capability, statistical controls and early-warning systems. Routine testing should increasingly happen at the point of manufacture, while Inito retains specification ownership, method governance, independent verification, investigation capability and technical oversight.

Key Responsibilities

QC Architecture & Control Strategy

• Define critical quality attributes, control points, specifications, sampling plans and acceptance criteria for assay-critical raw materials, intermediates and finished products.
• Link controls to product performance, risk and manufacturing capability; avoid both under-control and unnecessary testing.
• Establish governance for reference standards, retained samples, method ownership, independent verification and periodic requalification.

QC Methods & Measurement Systems

• Own or approve fit-for-purpose QC methods for antibodies, antigens, conjugates, membranes, pads, buffers, printed components, strips and finished kits.
• Qualify/validate methods and measurement systems for precision, range, robustness, operator/instrument effects, equivalence and relevant functional performance.
• Control reference materials, instruments, image-analysis systems, calculations and software used in release decisions.

Vendor QC Capability & Method Transfer

• Assess vendor laboratory capability before onboarding using audits, data review, method demonstrations and competency checks.
• Lead method transfer, analyst/instrument qualification and equivalence studies; define when vendor QC can be trusted without routine duplication.
• Establish clear quality-agreement responsibilities for testing, raw-data access, deviations, changes, escalation and release documentation.

Lot Release, OOS/OOT & CAPA

• Ensure complete, traceable batch-release packages and scientifically review vendor data beyond simple pass/fail status.
• Lead or technically support OOS/OOT, nonconformance and root-cause investigations, containment, CAPA effectiveness and requalification.
• Provide the technical QC recommendation for disposition; QA retains final quality disposition and QMS authority.

QC Data, SPC & Early Warning

• Define common QC data requirements and traceability from raw data through calculations, approvals and reported results.
• Build dashboards and statistical controls for precision/CV, yield, OOS/OOT, deviations, CAPA ageing, vendor trends, release readiness and data completeness.
• Detect drift and abnormal variation before specifications are breached and convert signals into investigation or control actions.

Stability, ORT & Product Surveillance

• Build risk-based ongoing reliability and stability programmes linked to shelf-life and product-performance claims.
• Connect retained-lot, complaint, return and field-quality signals to raw-material, process and vendor data to identify systemic trends.

NPI, Change Control & Audit Readiness

• Ensure methods, specifications, controls, reference materials, sampling and data requirements are ready before design transfer and commercial launch.
• Assess vendor/material/equipment/method/software/process changes for QC impact before implementation.
• Maintain inspection-ready QC records and support ISO 13485/FDA QMSR audits together with QA/RA.

Team Leadership

• Hire and develop a lean, technically strong QC team with clear ownership and competency matrices.
• Create operating cadences for vendor quality reviews, release readiness, investigations, CAPA follow-up and management reporting.

Required Qualifications

• 8-12 years of quality control, manufacturing quality or supplier quality experience in medical products, electronic medical devices, consumer electronics, diagnostics or other high-volume products, with meaningful ownership of external suppliers/CMs.
• Prior LFA or immunoassay experience is not required. Strong evidence of learning unfamiliar product technologies quickly and translating product function and failure modes into practical controls is required.
• Hands-on experience with specifications, sampling/inspection plans, acceptance tests, measurement-system qualification, supplier transfer, product release, reliability and investigations.
• Strong statistical judgement including trending, SPC, process capability and measurement-system analysis.
• Experience in a regulated quality system is preferred. Candidates from non-medical industries must demonstrate disciplined change control, traceability, CAPA, supplier quality and audit-ready operating practices.
• Demonstrated ability to audit suppliers and manufacturing processes, challenge weak data, drive corrective actions and influence engineering, manufacturing, sourcing, QA/RA and data teams.
• Bachelor's or Master's degree in Engineering, Science or another relevant technical discipline; equivalent technical depth through experience is acceptable.