Role & seniority: Quality Assurance Consultant (mid-to-senior level) responsible for QMS in local affiliates.

Stack/tools: Quality Management System (QMS), Learning Management System (LMS), GxP frameworks, CAPA, audits (internal/external), regulatory/compliance tools, QP/local product release, GDP oversight.

Top 3 responsibilities

Implement, maintain, and oversee the local QMS, Quality Manual, and Site Master File; ensure GxP surveillance and compliance.
Manage quality risk, deviations, complaints, CAPA from audits/self-inspections, and coordinate authority inspections.
Oversee local product release (local QP), GDP for warehousing/distribution, and return/recall processes; ensure quality review of shipments and transport performance.

Must-have skills

Bachelor’s degree in Quality Management, Life Sciences, or related field.
≥5 years in Quality Assurance within pharmaceutical/healthcare.
Strong knowledge of GxP, quality standards, and regulatory requirements.
Excellent analytical, problem-solving, and communication skills.
Ability to work independently and in teams; proficiency with QMS and LMS.

Nice-to-haves

Experience with supplier qualification/audits, change control, and supplier CAPA closure.
Background in local product recalls, repackaging/relabeling, and recall coordination.
Familiarity with training management and validation activities across sites.

Location & work type

Location: Local affiliates (regi

Full Description

Job Summary: The Quality Assurance Consultant is responsible for the implementation, maintenance, and oversight of the Quality Management System (QMS) in local affiliates. This role ensures compliance with regulatory requirements, quality standards, and company policies. The Quality Assurance Consultant will manage quality risk, complaints, change controls, deviations, CAPA, authority inspections, self-inspections, GxP surveillance, product quality reviews, training, local product release, and oversight of GDP requirements for local warehousing and distribution.

Key Responsibilities

QMS implementation, maintenance, and oversight in local affiliates.
Maintenance of the local Quality Manual and Site Master File.
Quality risk management in local affiliate, including risk identification, analysis, communication, control, and escalation as required.
Complaint management, acting as the Local Complaint Coordinator for reporting, local assessment, and local investigation.
Change control management, QA assessment, site change control, QA review for change implementation and closure.
Deviation management for internal, external, and transport deviations.
CAPA management from deviations, internal audits, external audits, and self-inspections.
Management of authority inspections and self-inspections.
Local GxP surveillance and assessment.
Product quality review (PQR).
Training management, including maintenance of training matrix, training of local staff, annual GxP refresher training, and handling of training assignments in the LMS.
Local product release (local QP), shipment review of transport performance, goods receipt check, and deviation handling.
Oversight of GDP requirements for local warehousing and distribution.
Shipping lane qualification and local transport performance of secondary distribution.
Secondary distribution transport performance review.
Return management, including QA evaluation against return criteria and collaboration with distributors.
Product recall management, including local recall execution, communication with customers, communication with HA, recall reconciliation, and local product destruction.
GxP suppliers management, including supplier identification, qualification, approval, annual compliance status evaluation, quality audit planning, conduct quality audits, and CAPA approval and closure.
Local repackaging and relabeling, including change management, protocol, execution, QA review, and release.

Qualifications

Bachelor's degree in Quality Management, Life Sciences, or a related field.

Quality Assurance Consultant