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Job: Manager, QA Clinical (30% Travel) - NC Pharma/Direct Hire, Frankel Staffing Partners, Research Triangle Park, NC
Manager, QA Clinical (30% Travel) - NC Pharma/Direct Hire
Research Triangle Park, NC 27709 United States
Our client, an RTP-based pharmaceutical firm that is undergoing significant growth, is actively recruiting for a skilled, knowledgeable and hands-on Clinical Quality Manager to provide QA oversight of clinical development activities and commercial products. Company will pay excellent wage to attract and retain an excellent candidate.
This is an exciting time for this company. It has multiple products in development and an approved compound. It is essential that the right people are in place to ensure clinical processes are conducted in accordance within SOPs and GCP guidelines. This Manager will play a key role.
Position will involve hands on oversight and management of all QA Clinical aspects internally and externally, to include coordination with cross functional teams - Clinical Operations, Project Management, Regulatory Operations - to establish and manage annual global GCP compliance activities. We seek an experienced and highly capable GCP Expert who will be responsible for establishing, maintaining and managing the GCP audit program.
This is an office based position with travel is estimated at 30%, globally.
Duties will include:
• Develop and implement QA Clinical plans to meet regulatory compliance goals
• Perform, coordinate and oversee domestic and international audits of investigator sites, documents, databases, vendors and internal systems
• Present audit findings to leadership
• Ensure appropriate implementation of Corrective and Preventive Action Plans are put in place based on audit findings, as well as track, review, approve, and assess the adequacy of CAPAs
• Involved in the selection, qualification and evaluation of CROs and other 3rd party partners
• Involved in the preparation, coordination, and management of regulatory agency inspections
• Review and update Clinical QA SOPS, training and procedures as needed
The right candidate will complement broad and deep knowledge of GCP, FDA / ROW and ICH regulations and practices with a hands-on, makes-things-happen work style.
Other priorities include:
• Bachelor’s Degree in a scientific discipline
• 7+ years of hands on QA Clinical experience
• GCP auditing experience with a company that has clinical stage development AND commercial products
• Strong oral and written communication skills
• Experience developing strategies and internal guidance’s as it relates to Clinical Quality
• Ability to successfully work with cross-functional teams.
• Global audit experience
Finally and critically, we seek a candidate who will thrive in a fast paced setting; one who has proactive and thoughtful “juggling” skills and the ability to handle a high level of activity in an evolving and exciting setting.
Many more details are available and I would be eager to get them to you. For now, I thank you for your time.
Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond). We specialize in Office Support, Life Science and other Professional Services positions. To view our current openings, please visit our website at www.frankelstaffing.com.
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