Advarra is the premier provider of institutional review board (IRB) services for human subjects research in North America. Fully accredited by AAHRPP, Advarra serves the world's leading pharmaceutical, biotechnology, medical device, and contract research organizations, as well as academic medical centers, health systems, investigative site networks, and therapeutic research consortia.

General Summary: The Manager, Quality Control is a Subject Matter Expert in the QC process and is responsible for providing direction to a team of Quality Control Coordinators. The position is responsible for conducting QC of all types of submissions and addressing any operational or performance barriers to ensure high accuracy, timeliness, and providing cross departmental customer service.

Principal Duties & Responsibilities:

Efficiently and effectively perform the duties of a Quality Control Coordinator

Operations Management

• Assess staff efficiency and effectiveness to ensure prompt and accurate completion of work
• Monitor and evaluate workload and allocate budgeted resources to meet service delivery obligations to address any customer impacting issues and report findings to the Director, Quality Control.
• Communicate expected performance levels and accountabilities to staff.
• Identify and recommend to the Director, Quality Control process changes to continuously improve Document Quality Control delivery.
• Implement and maintain department metrics.
• Serve as a Subject Matter Expert for QC staff.

Ensure Quality Customer Service

• Monitor and ensure staff performance standards are maintained to meet a high level of accuracy and timeliness.

• Maintain current and thorough working knowledge regarding IRB regulations and guidance.
• Address any identified staff errors in accordance with established procedures and provide follow up communication as necessary

Coaching and Mentoring

• Participate in team and department professional and personal development initiatives while maintaining a high level of integrity through cooperative and respectful interactions with colleagues.
• Ensure that employees receive training and support to provide accurate QC review.

• Allocate resources to meet service delivery obligations and recommend staffing changes to the Director, Quality Control.

• Coach, develop and provide training to Document Quality Control team.
• Provide input and recommendations to the Director, Quality Control, for the hiring, promotion, evaluation, performance improvement, and termination of employees within the team.

• Participate in team and department professional and personal development initiatives while maintaining a high level of integrity through cooperative and respectful interactions with colleagues.
• Performs other duties as assigned by the Director, Quality Control

Education

Bachelor's degree in health science or related field, or equivalent combination of education and experience

Experience

3-5 years leadership experience in a human subjects protection environment or related role

Certified IRB Professional (CIP) or attainment of CIP within one (1) year of eligibility

Knowledge, Skills, Abilities

• Detail oriented
• Developing and motivating teams
• Effective written communication skills and interpersonal skills
• Must have a high-level attention to detail, accuracy and thoroughness; problem solving skills
• Highly organized and efficient; Process and procedure oriented
• Excellent interpersonal skills to work professionally and effectively with others
• Ability to manage conflicting demands and priorities
• Knowledge of Federal regulations and guidelines pertaining to human subjects research, including the FDA, DHHS, and ICH
• Management of People and Supervision
• Knowledge of quality control
• Supervise a team
• Thrive in a fast-paced, changing, time-sensitive environment
• Perform highly complex duties
• Ability to implement and execute change accordingly
• Ability to analyze data to assess trends and issues impacting performance

Physical and Mental Requirements:

Sit or stand for extended periods of time at stationary workstation

Regularly carry, raise, and lower objects of up to 10 Lbs.

Learn and comprehend basic instructions

Focus and attention to tasks and responsibilities

Verbal communication; listening and understanding, responding and speaking

EEO Statement Advarra provides equal employment opportunity to all individuals regardless of their race, color, religion, creed, sex, sexual orientation, gender identity, national origin, age, disability, veteran, marital, or domestic partner status, citizenship, genetic information or any other status or characteristic covered by federal, state or local law. Further, the company takes affirmative action to ensure that applicants are employed, and employees are treated during employment without regard to any of these characteristics. Discrimination of any type will not be tolerated. EEO/M/F/Disabled/Vets