Overview
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Our client, a global biopharmaceutical organization, is seeking an Impact Quality Lead to implement and maintain a proactive approach to pharmacovigilance compliance. This role focuses on ensuring that all pharmacovigilance activities adhere to international regulatory requirements while providing strategic quality leadership across post-marketing programs.
Responsibilities
Provide global quality oversight for the pharmacovigilance system and the quality management system.
Deliver expert guidance on
GVP
and
GCP
regulatory expectations, including
FDA ,
EMA, and
ICH
guidelines.
Review and ensure compliance for pharmacovigilance outputs such as
ICSRs ,
DSURs ,
RMPs, and
REMS .
Manage vendor and partner oversight to ensure consistent and compliant delivery of delegated
GCP
and
GVP
activities.
Lead deviation management processes, including root cause analysis and the tracking of
CAPA
effectiveness.
Host and support regulatory inspections and audits by developing and implementing remediation plans.
Collaborate with cross-functional teams to drive quality process improvement initiatives and ensure inspection readiness.
Qualifications
You have a Bachelor’s degree in Life Sciences, Science, or Engineering.
You bring 8+ years of experience in
GVP ,
GCP, and
pharmacovigilance
within the pharmaceutical or biotech industry.
You possess extensive experience in quality assurance, including
CAPA ,
deviation management, and
audit
activities.
You have a demonstrated history of supporting global regulatory inspections and managing
GVP
quality systems.
You bring strong analytical, problem-solving, and communication skills with a focus on ethical standards.
You are fluent in
English .
Nice to Haves
Experience with
Veeva Systems
or the
Argus
global safety database. xphnsxz
Possession of a Master’s degree in a relevant scientific field.
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