A
Vendor Quality Lead
is being sought to strengthen the R&D & Pharmacovigilance Vendor Quality team.
This role will support
GCP-focused vendor qualification activities
,
quality agreement setup
, and
vendor oversight
, particularly due to a backlog of agreements and an increasing number of GCP vendors.
Team Information
* The team is part of
R&D and Pharmacovigilance Vendor Quality
within the global Quality organization.
* The team covers
GLP, GCP, and GVP
, but this position will focus primarily on
GCP
Typical Day
* Managing
GCP vendor qualification activities
.
* Handling the
setup, review, update, and closure of Quality Agreements
(priority focus).
* Supporting
risk-based vendor oversight
: governance meetings, issue escalation, documentation follow-up.
* Acting as the
QA point of contact
for deviations, investigations, and audit observations related to assigned vendors.
* Ensuring
inspection readiness
and compliance with
GCP and EMA/FDA/ICH requirements
.
* Collaborating with internal stakeholders: Quality Leads, Global QA, Procurement, Legal, IT/CSV.
* Interacting directly with vendor organizations regarding
performance, compliance, and governance
.
* Driving
continuous improvement
and contributing to
harmonization initiatives
.
What are we looking for?
* Minimum
10 years of relevant experience
.
* Strong seniority is required; candidates with only 5–6 years of experience
will not meet the expected level of expertise
.
Must-Have Skills
* Strong
GCP background
and understanding of clinical trial management.
* Proven experience in
vendor qualification and vendor management
.
* Solid experience in
Quality Agreements lifecycle management
.
* Knowledge of
regulatory requirements
(EMA/FDA/ICH).
* Experience with
risk-based oversight
and
CAPA lifecycle
.
* Fluent in
English
(mandatory).
* Comfortable with
digital tools and technological processes
.
* Strong
professional judgment
, ability to act independently, and manage complex situations.
Nice-to-Have Skills
* French
language skills (not mandatory; English is the working language).
* Experience with
Digital/IT systems
, data integrity, IT validation, eClinical tools.
* Legal or paralegal background
(advantageous for Quality Agreements).
* Experience with
AI-driven or digitalization initiatives
.
* Vendor management experience in additional
GxP areas
(excluding GMP/GDP profiles).