Indirizzo
Forma di lavoroAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe. As an Senior AuditorQA Compliance, you will be responsible for meeting all internal and external audit needs, including but not limited to internal process audits and sponsor-contracted project audits in line with GCP regulations. This is an ideal role to step into for someone from with a profound Clinical Operations background, with strong interpersonal skills and a natural flair to work in a methodical, detail-orientated and organized manner. What else can you expect from us?
- Rewarding and meaningful work in an established, diverse, highly profitable and respected global company
- Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, lunch vouchers, etc.
- A genuine work life balance
- Flexible work hours as per the guidelines in your country and in alignment with your team during working hours
- A thorough onboarding with support from your personal mentor
- A permanent employment contract with Fortrea
- Excellent training and career development opportunities, as well as support with advancing your individual education
- Strong support from your Line Manager and your team, as well as from more than 19,000 Fortrea colleagues worldwide
- Conduct work as identified e.g. in the audit activity table as per audit assignments
- Support the generation of global QA policies on both interpretation and application of regulations.
- Provide subject matter expertise, influence provide QA guidance our QA organization by providing guidance, and support external stakeholders on specific niche regulatory and compliance topics.
- Support Host hosting of external audits and inspections, e.g. regulatory inspections, strategic client meetings / audits, etc.
- Subsequently facilitate and review audit responses.
- Report on quality metrics, implement necessary corrective actions and/or process improvements via the appropriate forums (e.g. Monthly Reports, Site Quality Review, Liaison meetings).
- Support the QA-to-QA relationship with our sponsors.
- Deliver trainings in performance of audits.
- Participate in global quality initiatives aimed at improving compliance and/or efficiency of our QA organization.
- Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed.
- Depending on your seniority: act as a backup for the QA Manager and provide them with monthly activity reports.
- Degree in a relevant field such as pharmacology, (bio-)chemistry, biology, life sciences, health management, etc.
- In lieu of the above: an equivalent completed vocational training and / or equivalent professional experience in drug development, acquired either at a CRO or a pharmaceutical / biotech company
- Solid experience with quality systems and standards in drug development, e.g. due to solid professional experience as a CRA / site monitor
- Proven ability to apply appropriate regulatory knowledge to a variety of scenarios in clinical research
- Excellent interpersonal and organizational skills
- Flexibility to travel internationally (primarily in EMEA) occasionally is a must
- Business fluency in English (C1 and above) is a must, additional language skills are a plus
