Senior Auditor, Quality Assurance (Pharmacovigilance Audit/GCP Audit experience required)

Ergomed

About The Position

The Senior Auditor, Quality Assurance effectively manages and conducts internal and contracted audits for the Company and its clients. The role contributes to audit strategy and risk-based audit planning, leads process and complex audits, and provides QA consultancy within the auditor’s GxP expertise. The Senior Auditor conducts audits initiated by the Company or contracted by small to mid-size clients, managing pre-audit activities and following the agreed Audit Program. Audit work may cover Company partners and vendors/service providers, internal systems, studies and investigational sites, and third parties audited on behalf of clients, including MAH pharmacovigilance systems, vendors, and MAH affiliates or partners. The role reviews and approves final CAPA plans from contracted audits within required timelines. The position also serves as the main QA contact for designated clients, planning, conducting, and reporting on requested audits and supporting Quality as a Service activities. These may include mock inspections, training, gap analysis, and procedure drafting or revision. The Senior Auditor supports audits and inspections of the Company by clients, third parties, and regulatory authorities; helps develop and train auditors and other quality employees; and assists with the strategic internal audit program. The role requires maintaining current knowledge of international regulatory requirements, guidelines, and best practices, contributing to knowledge sharing and continuous development, and preparing or quality-checking audit strategies, SOPs, guidelines, and other audit procedures as operational needs require.

Requirements

Bachelor’s degree in a scientific discipline, or equivalent relevant industry experience.
Strong previous pharmaceutical and/or biotech pharmacovigilance experience.
Strong understanding of GVP- and GCP-related Quality Management and Assurance.
Previous GVP and GCP auditing experience in an Audit Lead role.
Analytical, written, and oral communication skills.
Ability to manage assigned tasks and deliver expected outputs in an organized and timely manner.
Ability to proactively communicate changes to established goals and deadlines.
Ability to think strategically and collaborate using risk-based, proactive approaches to problem-solving.
Strong team-player skills.
Fluency in written and spoken English.

Nice To Haves

Master’s degree.
Additional or local language skills.

Responsibilities

Conduct Company-initiated and contracted audits within the auditor’s GxP expertise, in accordance with the agreed Audit Program, including management of pre-audit activities.
Conduct audits of Company partners, vendors and service providers; internal systems; studies and investigational sites; and third parties on behalf of clients, including MAH PV systems, vendors, and MAH affiliates or partners.
Review and approve final CAPA plans from contracted audits within Company or client procedural timelines.
Provide QA consultancy, such as client PV or QMS system gap analysis and SOP development.
Act as the main QA contact for designated clients and plan, conduct, and report on client-requested audits.
Attend commercial meetings related to Quality as a Service.
Support clients with Quality as a Service activities, including mock inspections, training, gap analysis, and procedure drafting and revision.
Support audits and inspections of the Company conducted by clients, third parties, and regulatory authorities.
Work with Quality leadership to develop and train auditors and other quality employees.
Assist in developing the strategic internal audit program.
Maintain up-to-date knowledge of international regulatory requirements, guidelines, and best practices, and participate in knowledge sharing and continuous learning and development.
Prepare or quality-check audit strategies, SOPs, guidelines, and other documented audit procedures for the Company or clients, as operational needs require.