Senior Auditor, Vendor Audits

hace 5 meses


En remoto, España Premier Research A tiempo completo

At
**Premier Research,** we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

We’re looking for a
**Senior Auditor, Vendor Audits** to join our
**Corporate Quality** team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success. The role can be located in the EU country, where we have our entity.
- ** We are Built for You.** We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- ** We are Built by You.** Your ideas influence the way we work, and your voice matters here.
- ** We are Built with You.** As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
- Together, we are Built for BiotechSM.
** Join us and build your future here.**

**What you’ll be doing**:

- Organizes and hosts Vendor audits to support global operations (including preparation of audit plans, audit checklists, audit reports and certificates)
- Manages complex audit activities in accordance with the Premier Research Vendor audit schedule and ensures the approved vendor list remains up to date and that only approved vendors are listed as available for use at a study level
- Collaborates with operational teams to ensure any documented Vendor issues and/or gaps raised at a study level are reviewed on an ongoing basis and trended for potential systemic issues
- Acts as Point of Contact (POC) for vendor audit activities
- Ensures compliance with established internal control procedures by examining records, reports, operating practices, and documentation
- Complies with federal, state, and local security legal requirements by studying existing and new security legislation; enforcing adherence to requirements; advising management on needed actions
- Prepares special audit and control reports by collecting, analyzing, and summarizing operating information and trends
- Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies
- Ability to travel up to forty percent (40%) of time

**What we are searching for**:

- Bachelor’s degree preferably in a clinical, biological or science-related field or equivalent combination of education
- 5+ years of experience in audits (GCP or vendor audits)
- Clinical research experience on the CRO or pharmaceutical company side is essential
- Strong verbal and written communication skills in English
- Excellent team player, collaborative approach and ability to build an effective team
- Ability to be flexible
- Ability to multitask and work effectively in a fast-paced environment with changing priorities
- Excellent organizational and time-management skills, ability to prioritize work to meet deadlines

**Why choose Premier Research?**
- Premier Research is more than a company - it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our cultural anchors - Caring & Empathy, Empowerment, Aspiration, One Team - mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

LI-BC1
Remote



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