Senior Auditor, Quality Assurance

Ergomed; Lazio; On-site; EUR 60,000 - 90,000; Full time

Job summary

Ergomed Group is a leading provider of clinical research, pharmacovigilance, and quality consulting. The Senior Auditor, Quality Assurance role entails managing and conducting internal and contracted audits for the Company and Clients, guiding audit strategy and risk-based planning.

You will lead complex audits, act as main QA contact for designated clients, and contribute to Quality as a Service, including mock inspections, training and SOP development.

Qualifications

• Pharmaceutical/pharmacovigilance experience with GVP/GCP auditing.
• Strong analytical, written, and oral communication skills.
• Ability to manage multiple tasks and meet deadlines.

Responsibilities

• Lead internal and contracted audits per the Audit Program.
• Manage pre-audit activities and risk-based planning.
• Provide QA consultancy, SOP development and gap analysis.
• Act as main QA contact for designated Clients and audits.
• Support training and development of auditors.

Skills

Pharmacovigilance

GVP & GCP knowledge

Auditing

Analytical skills

Written and oral communication

Team player

English fluent

Education

Bachelor's degree in a scientific discipline

Master's degree preferred or equivalent experience

Job description

Medicine moves forward here. So will you.

Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so they experience more of life's meaningful moments. Biopharmaceutical companies are our clients. Patients are our purpose.

Ergomed Group brings together Ergomed CRO, PrimeVigilance, Prudentia, and ADAMAS Consulting to help biopharmaceutical companies develop, deliver and safeguard therapies in oncology, rare disease and other complex areas of medicine. Across the Group, our teams turn the signals that clinical trials, safety systems and quality data generate into insight that helps bring safer treatments to patients around the world.

The science and analysis that guides our work is demanding. And this is where we excel. What defines us, though, is how we work together. Across countries, cultures and time zones, we bring kindness, curiosity and a shared sense of purpose to work that genuinely matters. Ideas are welcome here. Growth is expected. And every person has room to make a real difference to patients' lives.

Whether you are early in your career or bringing decades of experience, we want you to feel valued for what you do and for who you are. If that sounds like the place you have been looking for, we would love to hear from you.

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 wall. If they sound like you, you will feel at home here.

Quality: we hold ourselves to the standard patients deserve.

Integrity and trust: we do the right thing, especially when it is hard.

Drive and passion: we care about the outcome, because someone is waiting on it.

Agility and responsiveness: we move quickly, because patients cannot wait.

Belonging: everyone is welcome, and every voice counts.

Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.