Manager - Clinical Quality Assurance (Oculos)
Oculos Clinical Research / iuvo BioScience is looking for a Manager- Clinical Quality Assurance (CQA). This position is responsible for assuring the proper planning, conduct and reporting of Clinical Quality Assurance audits and prepares for and supports the management of regulatory inspections. The CQA Manager provides guidance and shares expertise with Oculos staff in interpreting clinical development regulations and Good Clinical Practice (GCP) guidelines in a continued effort to mitigate/eliminate potential regulatory risks.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Independently conducts internal systems audits of various departments and procedures, and/or project specific audits as assigned. Prepares audit reports independently, with review by QA management as necessary.
- Oversees the efforts of contracted auditors, and forwards to QA management for final review.
- Suggests risk based internal and external audit targets (including study sites and/or vendors as commensurate with risks) to QA management; assure timely execution of the complete Audit Schedule to demonstrate compliance with company procedures and governing regulations
- Review standard operating procedures, work instructions and other process and/or quality management system related documents to ensure compliance with regulations
- Recommend continuous process improvement areas to management based on trends from audit findings, quality issues and other sources
- Provides oversight and directs training of the Clinical Operations staff (internal and external) in all aspects of the quality assurance function; especially as it relates to conducting and hosting auditing.
- Prepares and delivers internal and external presentations and audit results, as assigned, with review by QA management.
- Reviews, approves and assures completion of Corrective and Preventive Action (CAPA) plans identified via the audit process.
- Works in conjunction with the QA management to assure coordination of effort within the department and with external contracted staff to assure compliance throughout the clinical research process
- Interviews, coaches and reviews employee performance with assistance from other QA management team members.
- Presents CQA concerns to Oculos management, functional areas, and external customers as required.
- Performs other activities, as assigned, to support overall organization’s goals
Education: Bachelor’s degree in a scientific discipline: biology, chemistry or a health science strongly preferred
Experience: (Type of work experience, min. number of years):
Minimum of 3 years of QA experience, GCP (strongly preferred), and/or a minimum of 5 years of progressive clinical research experience (monitoring, project management and/or auditing); a graduate degree directly related to clinical research regulations and/or quality assurance may be considered in lieu of experience
Technical or Administrative Knowledge and Skills:
- Demonstrated knowledge of Good Clinical Practice regulations, guidance and standards, including US and global as these pertain to all phases of clinical development
- Experience supporting sponsor regulatory inspections, conducting clinical investigator site inspections and direct involvement in implementation of corrective and preventive actions in response to audit observations
Must have proofreading, spelling, grammar, and technical writing skills. Must have the ability to communicate effectively with customers or employees of the organization.
Ability to perform the calculations used in manipulating data.
Ability to analyze data and reach a conclusion, read, interpret, and relay requirements for testing to other employees.
OTHER SKILLS and ABILITIES
Project management, good organization, time management, reading, writing, proofreading and editing skills.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to sit, stand and walk, use hands to manipulate objects or controls, reach with hands and arms, talk and hear.
iuvo Bioscience is an Equal Opportunity Employer.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.