Controllo Qualita jobs in United States

PSI is a leading Contract Research Organization (CRO) with about 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.

At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.

We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.

PSI is looking for a business orientated Clinical Procurement Manager to join our global Vendor Management team. In this role you will develop tools and systems for vendor cost analysis, ongoing assessment and benchmarking. You will report into the Director, Vendor Management and support the development and implementation of PSI’s clinical procurement strategy.

Responsibilities

• Provide support for the vendor evaluation/selection process from a cost/commercial terms and market competitiveness perspective.
• Review market options for vendors and benchmarking of PSI vendor costs.
• Support the vendor contracting process (MSAs and Work Orders with various stakeholders.
• Support the monitoring of vendor performance, conducts cost analysis and KPI review.
• Ensure vendor cost compliance with contracts across clinical trials at PSI.
• Assess regulatory and operational risks associated with vendors.

Quality Control & Quality Assurance

• Support audit participation and inspections.
• Develop and implement processes for the procurement function.
• Support processes to ensure vendors comply with GCP, FDA, EMA and other relevant regulations.
• Develop vendor specific KPI’s related to cost aspects and monitors ongoing performance.

Business Development

• Assist in business development tasks (client meetings, vendor shows, vendor cost representations etc).
• Develop and oversee process requests for proposals to PSI vendors.
• Evaluate vendor proposals and costs to ensure PSI expectations are met.

• College or University Degree.
• Member of the Chartered Institute of Procurement & Supply (CIPS) or to be working towards it is a plus.
• At least 6 years’ clinical research experience.
• At least 4 years’ experience in vendor procurement, proposal review, clinical trial operations or working alongside or managing vendors.
• Proficiency in MS Office applications.

PSI is a passionate, organically grown, and award-winning full-service CRO who dares to be different. As a dynamic and global company, we bring together more than 3,000 driven and dedicated experts across 60 countries working collectively to help make a positive impact on patient lives.

How are we different?

PSI is privately owned by the very people who founded the company more than 25 years ago, and they’re still working here today. As a result, we have grown organically around the globe and have kept our company fully independent, giving us significant advantages and freedoms.

Being a Part of the Team

As a part of the PSI team, you will have a fair degree of ownership and autonomy to make nuanced country-and department-specific adjustments while nurturing the global PSI culture that unites us across six continents.

You will receive continuous support from your global peers and join a fast-paced, innovative, and results-oriented working environment with lean communication lines. We pride ourselves on being approachable, receptive to new ideas, and open to feedback.

PSI is proud to invest in our people, from entry-level team members to senior leaders, helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.

The PSI Advantage

PSI CRO has been named a 2022 CRO Leadership Award Champion in the categories of Compatibility, Quality, and Reliability across two respondent groups (Overall and Small Pharma). This is the fourth year in a row that PSI CRO received CRO Leadership Awards in all 5 categories, also including Expertise and Capabilities. The CRO Leadership Awards are presented by Life Sciences Leader and Clinical Leader based on research conducted by ISR reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

If you’re looking to advance your career in clinical research at a company growing organically into new regions around the world, we would love to hear from you! Global CROs don’t expand their business to new locations every day, so don’t miss your chance.