Senior Auditor, Quality Assurance

Ergomed; United States; Remote; USD 110,000 - 160,000; Full time

Job summary

Ergomed seeks a Senior Auditor, Quality Assurance to manage internal and contracted audits across GxP areas, providing strategic input to audit planning and risk-based approaches. The role includes leading complex audits, CAPA reviews, and QA consultancy for clients within the pharma/biotech sectors.

The candidate will act as main QA contact for designated clients, support training, SOP drafting, and continuous improvement initiatives while maintaining up-to-date regulatory knowledge.

Qualifications

• Strong pharmacovigilance and QA knowledge in GVP/GCP.
• Auditing experience in an Audit Lead role.
• Ability to manage tasks and deliverables in a timely manner.
• Think strategically with risk-based, proactive problem solving.
• Fluent in English; additional languages are a plus.

Responsibilities

• Manage and conduct internal and contracted audits per Audit Program.
• Lead process and complex audits across GxP areas.
• Provide QA consultancy, SOP development and CAPA reviews.
• Serve as main QA contact for designated clients and audits.
• Support training, gap analyses, and audit strategy documentation.

Skills

QA auditing

Pharmacovigilance experience

Analytical skills

Written and oral communication

Risk-based problem solving

Team player

English fluency

Education

Bachelor's degree in a scientific discipline

Master’s degree preferred or equivalent experience

Job description

Job Description

The Senior Auditor, Quality Assurance role is a senior role that effectively manages and conducts internal and contracted audits for the Company and for Company’s Clients. The role provides input into audit strategy and risk-based audit planning and leads process and complex audits, as well as providing QA consultancy activities within their area of GxP expertise.

Core responsibilities of the Senior Auditor are:

• Auditing
• Within area of their GxP expertise, conduct audits initiated by the Company, or contracted by small to mid-size Clients, according to the agreed Audit Program including effective management of pre-audit activities.

Audit types may include:

• • Audits of Company Partners and Vendors/Service Providers
  • Internal System Audits
  • Study audits (e.g. of study files, investigational sites)
  • Audits of Third Parties on behalf of Clients (e.g. including MAH PV System, Vendors, MAH Affiliate/ Partner Audits).
    • Reviews and approves all final CAPA plans from contracted audits within timelines mandated by Company/ Client procedures
  • Consultancies e.g. Client PV / QMS system gap analysis, SOP development, etc.
• Main QA contact for designated Clients and plans, conducts and reports on audits requested by Clients
• Quality as a Service
  • Attend commercial meetings related to Quality as a Service
  • Supports Clients with a wide variety of Quality as a Service activities, including
    • Mock inspections
    • Training
    • Gap analysis
    • Procedure drafting and revision
• Other
  • Supports audits and inspections of the Company performed by Clients/third parties and regulatory authorities
  • Works with the Quality leadership to develop and train Auditors and other quality employees
  • Assists in the development of strategic internal audit program
  • Maintain an up-to‑date knowledge of international regulatory requirements, guidelines and best practices and actively participate in knowledge‑sharing and learning process to ensure personal and team continuous learning and development
  • Participate in preparation (authoring or QC) of audit strategy, SOPs, guidelines and other documented procedures required for auditing activity of the Company and/or Client as per operational needs

• Bachelor’s degree in a scientific discipline required; Master’s degree preferred, or equivalent relevant industry experience.

Experience

• Strong previous pharmaceutical and/or biotech pharmacovigilance experience, including strong understanding of GVP & GCP related Quality Management and Assurance, with previous experience of GVP and GCP auditing experience in an Audit Lead role.
• Analytical, written and oral communication skills
• Ability to manage all tasks assigned and effectively deliver all expected deliverables in an organized and a timely manner
• Proactively communicate changes in pre-established goals and deadlines
• Ability to think strategically and to work collaboratively using risk-based, proactive approaches to problem-solving
• Strong team player
• Fluent in English (written and spoken); additional/ local languages a plus, but not required

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a