Summary:

Conduct audits according to plan in support of Clinical programs. Work with Clinical Staff to resolve audit findings and offer suggestions for improvement. Serve as a resource for Clinical staff regarding issues of compliance within area of expertise. Communicate issues to department management.

Primary responsibilities:

• Plan and conduct in-depth audits of CROs, vendors, clinical trial sites, and documentation associated with clinical trials. Assess compliance with applicable regulations and standards.
• Conduct internal audits of Clinical GCP processes for adherence to SOPs, company policy, and regulations/standards.
• Prepare audit reports and discuss findings with auditees and internal customers. Track and follow up on the resolution of audit findings.
• Assist in the conduct of GXP audits as assigned.
• Provide guidance to Clinical staff in resolving audit findings in a compliant manner.
• Assist internal groups in preparing for inspections by regulatory agencies and participate in on site regulatory inspections as appropriate.
• Requires travel to CRO, vendor, and/or clinical trial sites

Knowledge, skills, & abilities:

Good knowledge of regulatory requirements and guidances including GCP, GCLP, GLP, and/or medical device areas. Has experience in interpretation and implementation of these regulations and guidances in Clinical QA.

Excellent written and oral communication skills. Good interpersonal relations and influence skills.

Ability to define risk as it relates to specific non-conformances or trends and work with clients to mitigate identified risks.

Requirements:

A Bachelor of Science degree in pharmaceuticals or life sciences related field is required and more than 5 years professional employment in industrial positions with practical experience across GLP, device and GCP quality assurance.

Experience in Quality Systems application in the Development setting. Working knowledge of GCP, GCLP, GLP and/or Medical Device regulation and application to GXP studies. Experience in QMS management in GMP settings may also be included in determining suitable experience.

Schedule:

1st shift, Monday-Friday

Occupational demands:

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues

EEO Minorities/Women/Disabled/Veterans

Location: NORTH AMERICA : USA : NC-RTP:USNC0003 - RTP NC-Research Building 85

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