Quality Assurance and Auditing Manager

24 Jun, 2024

Context

The Penta Foundation is a non-profit organisation promoting activities related to research on HIV and other paediatric diseases, principally infectious diseases. It coordinates a global network of clinicians and researchers, who conduct research aimed at improving the health and lives of women and children.

The Foundation sponsors observational studies and clinical trials according to the GCP guidelines and other relevant European Directives. It is a centre for project development and management and for the collection and dissemination of information on paediatric infectious diseases related issues. It also coordinates training programs for health providers.

The Penta Foundation strongly believes in people development, in education and training dedicated to its own staff member. It funds every year specialisation courses and masters dedicated to the staff through a transparent Call for proposal.

Job Title

Quality Assurance and Auditing Manager

Reports to

Chief People, Culture and Communication Officer

Job responsibilities

  • Negotiate and agree in-house quality standards with the Senior Management.
  • Develop QA plans, identify critical control points and preventive measures.
  • Establish critical limits, monitor procedures, corrective actions, verification procedures.
  • Define supplier’s qualification and monitoring.
  • Provide guidance to operational area managers of the Foundation for the design, implementation of the process policies and procedures, ensuring compliance with all applicable rules and regulations, guidance, and standards.
  • Provide independent reporting on quality compliance to the Board of Directors.

The post holder will be expected to be fluent in English and to have excellent verbal and written communication skills enabling close work with the collaborating institutions and clear communication between the project/study collaborators.

This post provides an exciting opportunity for someone with a track record in Quality Assurance and an interest in clinical research.

The position is based at the Penta Foundation headquarters in Padova, with the possibility of smart working depending on the seniority of the applicant.

Key responsibilities

  • Support the operating staff in the implementation of GCP-related quality system SOPs in compliance with applicable regulatory requirements and best practice.
  • Manage evaluation and approval of quality system documentation including but not limited to deviations, change control reports, and document changes for compliance requirements (SOPs, procedures, policies, etc.).
  • 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 Clinical/QA practices.
  • Provide leadership and represent Quality Assurance on cross-functional project teams evaluating new quality processes or systems for Projects and Phase I/II/III/IV studies’ operations.
  • Direct and oversee inspection readiness activities and investigations to resolve quality issues. Review and approve corrective/preventive actions to reported audit observations and ensures proper follow-up activities are completed and documented.

Requirements

  • University Degree or B.S./M.S. in a relevant science field.
  • Pharmaceutical QA and clinical operations experience.
  • Current and strong working knowledge interpretation/implementation of EU Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research.
  • Ability to deal with ambiguity leading to creative and pragmatic solutions to GCP compliance risk areas.
  • Experience supporting regulatory authority inspections is desired.
  • Thorough grasp of operational issues and performance standards for QA including key performance metrics.
  • Proven ability to work under tight deadlines and pressure in an organized manner.
  • Ability to organize tasks with exceptional attention to details, to work independently with minimal supervision and to adapt to changing priorities.
  • Ability to work well in teams and manage multiple projects while maintaining quality.
  • Excellent communication skills, both verbally and in writing. Ability to influence and advocate course of action of research project.
  • Advanced software skills (Microsoft Office suite proficiency including Office Word, Excel, PowerPoint and SharePoint).
  • Able to read, write and speak fluently the English language.
  • Able to travel approximately 10%-20% both domestically and internationally including overnight stays.

Soft skills

  • Organisational and time management skills
  • Result orientation and ability to manage priorities
  • Attention to detail and accuracy
  • Enthusiasm and flexibility, but also fairness and precision
  • Enthusiasm in working in a multicultural environment
  • Good relationship and communication skills
  • Attitude to teamwork
  • Ability in finding/proposing solution to a problem without losing the focus
  • Command of the main Office applications; willingness to learn to use new tools
  • Collaborative, enthusiast, keen to continue learning
  • Eager to learn how to integrate legal knowledge with business understanding
  • Enthusiasm and willingness to roll up sleeves and learn
  • A mindset to take initiative and be pro-active on addressing new matters or challenges.

Salary

47.000 euro + 1.200,00 euro of Welfare Package + Penta Company Welfare System

Blind recruitment policy

Penta Foundation is committed in performing a blind recruitment process to prevent the influence of biases in the choice of new staff members, guaranteeing the anonimity of candidates. Following up to Penta’s internal SOPs and policies about gender equality and inclusion, in the strive towards Diversity, Equity and Inclusion, the recruitment is blind until the very last stage, when in-person interviews need to be performed. Therefore, until the final stage, all elements characterising the individual, or enabling to a partial or total identification of the candidate are removed. The characterising elements may include: name, surname, e- mail, picture, age, sex, religion, sexual orientation, national origin, disabilities, genetic information, pregnancy, parenthood, etc.

We are an Equal Opportunity employer

The 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, religion, sexual orientation, 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. The Penta Foundation makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Your Privacy matters to us

If you decide to apply for this position, you accept that Penta processes your Personal Data. If you want to know how your personal data will be processed by Penta, access the following link.