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.