Senior Manager, Clinical Quality

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.