GVP QA Auditing Manager
Our client, a global Biopharma company, now have approval to hire a GVP QA Auditing Manager working as part of the Clinical Quality Assurance group within Global Quality Assurance in an entrepreneurial and fast-paced environment. This position has flexibility for remote work in Ireland or the UK. Some travel maybe required.
The successful candidate will ensure the PV system vendors, commercial partners, global Clinical Quality and associated teams are operating in line with all applicable regulations and standards in support of the QMS & PV system.
Additionally, this hire will support Global Clinical Quality leaders in providing strategic input and tactical implementation for pharmacovigilance system activities and projects, identify and communicate compliance risks, and oversee action plans to mitigate risks. This hire will participate in inspections and inspection-readiness activities.
The ideal candidate will be a GVP QA Auditing Manager, with depth of audit experience in PV supporting the execution of Global PV system audit strategy, Clinical Quality Assurance in Biopharma, Pharma or CRO industries.
Requirements for GVP QA Auditing Manager:
SME for local and international regulations relative to pharmacovigilance system and quality.
Contribute to the execution of Global PV system audit strategy, and implementation within the QMS.
Perform reviews on internal and external SOPs; participate in the development of SOPs for Quality or PV System stakeholders.
Support updates of the quality related sections in the Pharmacovigilance System Master File (PSMF) or similar documents.
Perform, execute and evaluate PV-System auditee risk assessments.
Coordinate and implement strategic audit plans for pharmacovigilance system activities that include service providers, vendors, business partners, and internal audits.
Participate as auditor/co-auditor and/or manage the relationship with the vendor for all PV auditing.
Present QA findings/observations to in-house staff and to the responsible service provider, vendor, or partner company, as required.
Contribute to the evaluation of CAPA findings to identify quality-related signals and trends for improvement; ensure adequate and timely closure of CAPAs generated from audits.
Participate in inspection readiness and inspections as assigned. May perform one or more inspection roles during an inspection (e.g. inspection readiness training, runner, scribe, backroom lead, SME preparation, QA checks, etc.).
Requirements for GVP QA Auditing Manager:
Bachelor’s degree in a related field is required; Master’s degree in management, leadership or scientific discipline is desirable.
GVP lead auditor certification is preferred, with 5+ years GVP auditing experience.
Established Pharmacovigilance and proven Quality Assurance GVP knowledge & expertise.
Knowledge of post-authorization commitment requirements is preferred (Phase IV, PASS Studies) and Managed Access Programs (PSPs/MRPs, Early access etc.) is desirable.
Knowledge and experience with GCP, GLP, and GDP is a plus.
Inspection experience with FDA, MHRA (or other EU Competent Authorities); experience with emerging markets Regulatory Authority such as PMDA a plus.
Proven ability to collaborate and partner with various internal and external business partners.
Detail orientated, with excellent written and verbal communications skills.
Self-motivated, disciplined, and strong time management skills.
Please contact Larry on +353 (0) 1 2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. http://www.rftgroup.ie/