Summary of the position:
The Quality Assurance Manager II assists the Director, QMSS and Director, Quality Assurance, S. A. with the development and implementation of a broad spectrum of quality activities to demonstrate , document, and report compliance with client expectations in accordance with relevant guidelines and regulations. The Quality Assurance Manager II may also assist with training compliance and document administration by helping to coordinate the flow of documents through ZenQMS, ensuring compliance with training curricula, and tracking and trending associated metrics.
Essential functions:
Maintain knowledge of current and new regulations and guidelines and assist with their integration into the FHI Clinical Global Quality Management System.
In coordination with functional leadership, develop and maintain policies and procedures that align with FHI Clinical’s mission and values, ICH GCP guidelines, and relevant regulations.
Develop and implement internal audit plans according to the QMSS Annual Work Plan, performing internal audits as assigned to assess and monitor compliance with FHI Clinical Standard Operating Procedures, Policies, and study-specific plans.
Develop and implement audit plans as assigned for fulfillment of contractual obligations and vendor qualification requirements.
Serve as co-host of audits of FHI Clinical, assisting with coordination of documents and presentations prior to, during, and after audits. Assist with coordination and review of audit responses from various functional areas.
Serve as a GCP and regulatory resource to the project teams, assisting with quality oversight of projects, including tracking and trending of quality and risk metrics, as assigned.
Other duties as assigned.
Knowledge, skills, and abilities:
Knowledgeable in the content and application of clinical research processes, GxP, and other relevant requirements of major regulatory agencies (e.g., FDA, EMA, PMDA, SAHPRA).
Highly effective oral and written English communication skills.
Strong time management, follow-up, and organizational skills, with specific emphasis on attention to detail
Problem solving/process improvement skills with the ability to be part of and own solutions
Ability to work well independently, as part of a team, and in a coaching role.
Position Requirements:
Education: Bachelor’s Degree or the equivalent
Preferred Job-related Experience: At least 6 years in a clinical research setting with increasing Quality Assurance responsibility is required. Proficiency with Microsoft Office applications (e.g., MS Word, MS Excel, MS PowerPoint, MS Teams, MS Power BI, as applicable). Experience with ZenQMS or similar document repository system
Preferences: Experience in a dedicated auditing role.
Special Position Requirements: valid driver’s license and passport, ability to travel
Physical Expectations:
Typical office environment.
Ability to sit or stand for extended periods of time.
Ability to move 5-15 lbs.
Travel Requirements:
Expected travel time is 25% for this position.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.
FHI Clinical, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.
This job posting 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 is an equal opportunity 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, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.
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