Quality Assurance & Auditing Manager - #48524

Fondazione Penta ETS (penta-id.org) is looking for a Quality Assurance & Auditing Manager.

Job Responsibilities

The Quality Assurance & Auditing Manager role provides an exciting opportunity for someone with a track record in Quality Assurance and an interest in clinical research. Success in this position involves effectively managing quality standards, developing QA plans, performing audits, and implementing risk management strategies. This role is crucial for ensuring compliance with regulatory requirements and best practices, thereby supporting the company’s overall mission to maintain high-quality standards and continuous improvement.

Reports To

The Quality Assurance & Auditing Manager will report to the Chief of Department.

Job Duties

• Develop QA plans with each team leader, identify critical control points and mitigation strategies
• Perform supplier qualification and monitoring
• Perform audits (internal and external)
• Implement risk management and in-house quality standards at company level to be negotiated with the senior management
• Handle deviations and corrective action / preventive actions (CAPA).
• Manage trainings at company level
• Represent QA in cross-functional project teams that among other things, but not limited to, provide quality guidance and evaluate new processes or quality systems for projects and Phase I/II/III/IV studies
• Manage and approve controlled documents (SOPs, policies and work instructions)
• Provide independent reporting on quality compliance to the Board of Directors.
• Support the operating staff in the implementation of GCP-related quality system SOPs in
• compliance with applicable regulatory requirements and best practice.
• Provide leadership and oversight for continuous process improvement as new issues are detected, new knowledge becomes available, or change in regulation that add greater reliability, compliance, efficiency, and drive change.
• Provide QA advice based on analysis and interpretation of updates to GCP regulations to assure best QA practices.
• Direct and oversee inspection readiness activities and investigations to resolve quality issues.
• Give support to and approve activities related to software validation
• Give support to all Penta Staff Members in the matter of quality management
• Review and approve corrective/preventive actions to reported audit observations and ensures proper follow-up activities are completed and documented.

Skills and Qualifications

Education level:

• University degree or Bachelor Degree of Science/Master Degree in life sciences, preferably pharmaceutical sciences

Experience:

• Pharmaceutical Quality Assurance and Clinical Quality Assurance experience
• Experience in auditing

Specific skills:

• Current and strong working knowledge interpretation/implementation of EU Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research.
• Risk Management Knowledge
• Thorough grasp of operational issues and performance standards for QA including key performance metrics
• Ability in finding/proposing solution to a problem, also to GCP compliance risk areas, without losing the focus
• Result orientation and ability to manage priorities, tight deadlines and pressure
• Languages: good knowledge of Italian and English (written and oral at least B2 level)
• Excellent communication skills, both verbally and in writing
• Ability to organize tasks with exceptional attention to details, to work independently with minimal supervision and to adapt to changing priorities.
• Experience supporting regulatory authority inspections is desired
• Command of the main Office applications (Microsoft Office suite proficiency including Office Word, Excel, PowerPoint and SharePoint); willingness to learn to use new tools

Personal characteristics:

• A mindset to take initiative and be pro-active on addressing new matters or challenges
• Attitude to teamwork
• Enthusiasm and willingness to roll up sleeves and learn
• Collaborative, enthusiast, keen to continue learning
• Enthusiasm in working in a multicultural environment, flexibility
• Organisational and time management skills
• Attention to detail and accuracy
• Eager to learn
• Ability to travel approximately 10%-20% both domestically and internationally including overnight stays.

Certifications:

• Lead Auditor (ISO 19011)
• GCP – Good Clinical Practices
• ISO 9001 (desirable)
• PdR 125:2022 (desirable)

Type of contract

Permanent contract with a hybrid work arrangement: 3 days on-site in Padua, Italy and 2 days remote.

Salary

45.000 € (annual gross salary) + company welfare + meal vouchers.

How to apply

Send your CV to [email protected].

We are an equal opportunity employer

Penta Foundation is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on sex, gender, sexual orientation, religion, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organisation, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.

Penta Foundation makes hiring decisions based solely on qualifications, merit, and business needs at the time by using a blind recruitment procedure.

https://penta-id.org/who-we-are/diversity-and-inclusion/

Privacy notice

Before submitting your application, please read our Privacy Notice and learn how we handle your personal data.

https://penta-id.org/wp-content/uploads/2026/05/Mod.-HR1_Recruitment-Candidate_Privacy-Notice.pdf