fhi360 Manager, Quality Assurance & Compliance in Durham, North Carolina
Develops positive and proactive approaches to clinical and regulatory compliance to ensure that quality policies, procedures, programs, systems and software meet applicable regulatory and validation requirements, and are consistent with internal Quality Assurance goals and initiatives. Manages the coordination and preparation of internal and external audits and compliance in accordance with regulatory standards and/or sponsor requirements. Coordinates audit follow-up and corrective action planning. Leads training of functional areas and assists in the development of training sessions. Oversees all interactions during regulatory agency inspections. Directs interaction with regulatory agencies and/or sponsors on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. Provides guidance on interpretation and application of specified regulations. Selects, develops and evaluates personnel to ensure the efficient operation of the function.
Leads the process for compliance among functional areas and implementing compliance initiatives.
Manages the coordination of internal and external audits to comply with required regulations and standards.
Provides training to functional areas and develops/assists with the development of training sessions.
Writes, reviews, revises, and approves control documents as needed.
Coordinates follow up and corrective action planning for internal and external audits.
Prepares compliance reports to management and regulatory agencies and/or sponsors.
Oversees assigned staff with compliance initiatives, audits, documentation and training with government regulations.
Participates in proposals and resources development.
Provide project management oversight for QA and Compliance related tasks and activities.
Performs other duties assigned.
Supports performance management and professional development of direct reports, including ongoing feedback, coaching, and career support.
Applied Knowledge & Skills:
Strong knowledge of quality management systems, regulatory standards and procedures among research industry.
Excellent oral and written communication skills.
Strong analytical and problem solving skills.
Ability to influence, motivate and negotiate to ensure compliance objectives are met.
Ability to analyze and interpret data, identify errors and prepare reports.
Demonstrated ability to create and manage work plans and timelines.
Problem Solving & Impact:
Works on problems of diverse scope that require analysis of data and evaluation of identifiable factors.
Exercises judgment within defined policies and procedures in selecting methods and techniques for obtaining solutions.
Decisions made generally affect specific functional area with cost and failure to achieve short term goals of the company.
Manages staff to meet departmental and organizational goals.
Develops value added solutions to meet internal and external needs of the company and department.
Typically reports to an Associate Director or Director.
- Bachelor's Degree or its International Equivalent • Life Sciences, Communications, Journalism, Public Health or Related Field.
Typically requires 5-8 years of management experience with compliance according to regulatory standards.
Articulate, professional and able to communicate in a clear, positive manner with clients and staff.
Must be able to read, write and speak fluent English; fluent in host country language as appropriate.
Prior management experience preferred.
Prior work experience in a non-governmental organization (NGO).
Typical Physical Demands:
- Typical office environment. Ability to sit and stand for extended periods of time; ability to lift 5-50 lbs.
Technology to be Used:
- Personal Computer, Microsoft Office (i.e. Word, Excel, PowerPoint, etc.), e-mail, telephone, printer, calculator, copier, cell phones, PDAs and other hand held devices.
This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.
Please click here to continue searching FHI 360's Career Portal.FHI 360 is an equal opportunity and affirmative action employer. FHI 360 is an equal employment and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, disability, veteran status, genetic information or any other status or characteristic protected under applicable law.
FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research, technology, communication and social marketing — creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 60 countries and all U.S. states and territories.
As we evolve to meet the challenges of the future, we stand committed to the principles that have guided our organization for the last 40+ years. Our work continues to be grounded in research and science, strengthened by partnerships and focused on building the capacity of individuals, communities and countries to succeed.