Quality Manager - CFSP
Descripción del trabajo
Join us in our exciting journey!!
IQVIA is expanding in EMEA!! We currently have a Quality Manager to work sponsor-dedicated to one of our pharmaceutical clients
This role provides advice and supports clinical staff and other relevant key stakeholders with regard to quality control, risk management, and corrective/preventive actions.
- Perform preliminary consultation, assessment and triaging of quality events that require intervention from the sponsor quality organization
- Perform trend analysis of quality events and process non-conformances
- Provide advice and support to teams on aspects of Good Clinical Practice (GCP), and Good Pharmacovigilance (GVP).
- Work in close cooperation with teams to manage non-compliance, quality issues, support in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs.
- Manage quality events within the customer eQMS (TrackWise)
- Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
- Upon agreement with the line manager: Perform any other reasonable tasks as required by the role.;
- Bachelor's Degree Bachelor's Degree in Life Science or equivalent field of study.Advanced degree preferred.
- Minimum of 8-10 years of experience in clinical research area inclusive of, but not limited to, Good Clinical Practice or Good Clinical Practice quality assurance and compliance.
- Established knowledge of GxP/GCP regulations and guidelines (EMA, FDA, PMDA etc.)
- Significant experience with GxP investigations, risk assessments and CAPA management.
- Experience participating in regulatory inspections.
- Functional planning experience and ability to develop functional vision, priorities and tactics.
- Experience with multinational products and regulations as well as with mandated risk management plans.
- Experience in managing, mentoring and directing people
- Ability to travel up to 10%.
- Fluent in English.
What we offer
- Focus on quality, not quantity! We invest in keeping our teams stable, so workload is consistent.
- The chance to work on cutting edge medicines right at the forefront of drug development.
- Genuine career development opportunities for those who want to grow as part of the organization.
- Flexible conditions and an attractive remuneration package.
- Home-based roles anywhere in EMEA!
We invite you to join IQVIA™
- Recognized by Great Place to Work as the second best company to work for in Spain (March 2019)
- FORTUNE Magazine's World's Most Admired Companies list for the third year in a row (January 2021)
- Recognized by the 2016 Scrip Awards as the Best Full-service Provider Contract Research Organization (CRO)
- Awarded the 2016 Eagle Award from the Society for Clinical Research Sites (SCRS) for the fourth consecutive year.
- A site-nominated award recognizing contract research organizations (CRO) and biopharmaceutical sponsors dedicated to building positive relationships with research sites through leadership, professionalism and integrity.
- IQVIA™ named in The International Association of Outsourcing Professionals (IAOP) 2017 Global Outsourcing 100® List which recognizes the world’s best service providers across a range of industries.
IQVIA™ is an equal opportunity employer. We make employment decisions based on qualifications and merit. We prohibit discrimination based on any unlawful consideration such as age, race, national origin, gender or other "protected status.“
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and whatever your career goals, we are here to ensure you get there!
Are you interested or do you know the ideal candidate?
- If you know the right candidate or for more information on this role please contact firstname.lastname@example.org
- Please note is necessary that your application is registered in our Talent Network (WorkDay) to process your candidacy
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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