Welcome to Orano
Helping to meet current and future challenges to preserve our world and build the world of tomorrow while taking care of everyone's health is stimulating for you. For us too. By joining the Orano Group, a leading international player in the nuclear industry, you are in the right place.
Every day we work to produce efficient low-carbon energy, to fight global warming, to find solutions that save natural resources, and to contribute to progress in health.
Our strengths? Across the entire fuel cycle, we have extensive expertise in cutting-edge technologies, safe, high value-added products and services, and a strong capacity for innovation. All of these factors reflect the strong skills of our 17,000 employees, whom we are constantly striving to develop. With their different backgrounds and experience, they are proof of our openness to all talents. They share the same ambition: to give nuclear energy its full value.
Every day we work to produce efficient low-carbon energy, to fight global warming, to find solutions that save natural resources, and to contribute to progress in health.
Our strengths? Across the entire fuel cycle, we have extensive expertise in cutting-edge technologies, safe, high value-added products and services, and a strong capacity for innovation. All of these factors reflect the strong skills of our 17,000 employees, whom we are constantly striving to develop. With their different backgrounds and experience, they are proof of our openness to all talents. They share the same ambition: to give nuclear energy its full value.
Job description
General Summary:
The Sr. Manager of Clinical Quality will be responsible for building out and managing quality management infrastructure for the clinical development organization. The role will be responsible for leading process development, managing department training matrices, owning the CAPA and deviation process, coordinating contracted audits and driving inspection readiness activities.
Job Duties and Responsibilities:
- Provide oversight and management of the clinical quality management system including driving clinical process development and improvement, managing periodic review of department SOPs and department training matrices.
- Implement and manage the clinical process deviation and corrective and preventive action (CAPA) process.
- Implement periodic quality reviews with department leadership.
- Coordinate clinical QA audits including investigative site audits and service provider qualification audits.
- Maintain listing of audits conducted, obtain timely and adequate audit finding responses, scheduled requalification audits as appropriate.
- Maintain clinical quality related records (qualified service provider list, audit related documents).
- Oversee inspection readiness activities (set up of inspection hosting logistics, facilitating mock inspections, implementation of inspection related communication plans with external parties, driving storyboarding activities etc) and host / assist in hosting health authority GCP related inspections.
Our Full-Time Benefits
- Competitive compensation
- Health, Dental, and Vision insurance – with generous employer contributions
- 401(k) with employer matching and contribution amounts
- Life insurance and Short- and Long-Term Disability insurance provided by the company
- Generous Paid Time Off and holiday schedules
- Numerous Training and Development opportunities
- and more…
Ideal qualifications
All candidates must meet the following minimum requirements in order to be considered for this opportunity.
Minimum Qualifications:
- Bachelor’s degree in life sciences, pharmacy, nursing, or a related field; advanced degree preferred.
- Minimum of 5-7 years of experience in clinical operations, quality management, or a related role within the pharmaceutical or biotechnology industry.
- Demonstrated experience in leading inspection preparation and hosting inspections.
- Prior experience in Clinical Quality Assurance or Clinical Quality (Management).
Differentiating Qualifications:
- Experience in a start-up environment is a plus.
- Prior experience as a clinical QA auditor.
- Experience with Dot Compliance QMS platform.
Skills and Knowledge Required:
- Strong understanding of clinical trial processes, GCP, and regulatory requirements.
- Proven track record in quality management and operational excellence in a clinical setting.
- Excellent analytical and problem-solving skills.
- Strong leadership and project management abilities.
- Exceptional communication and interpersonal skills.
Orano is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability, citizenship, veteran status, marital status, sexual orientation, gender identity, genetic predisposition or carrier status or any other characteristic protected by law.
Orano Med
Orano Med is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the production of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative radioligand therapies which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells. With a solid portfolio of molecules in development capable of targeting various forms of cancer, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular for patients with currently unmet medical needs.
Find out more about Orano Med
Find out more about Orano Med
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