Director, Quality Management

Summary

Join our dynamic global company as a Quality Management professional! You will play a key role in resource allocation, staff training, and regulatory agency interactions. Responsibilities include overseeing audits, investigations, and quality system documentation. You will need extensive experience in clinical research and quality assurance auditing, along with strong communication and organizational skills. A college degree and at least 7 years of clinical research experience are required. This position offers the opportunity to contribute to a company dedicated to improving lives through medical science.

Requirements

• Possess a college or university degree
• Have a minimum of 7 years of experience in Clinical Research
• Have a minimum of 5 years of industry experience in the capacity of a QA auditor or equivalent
• Have experience in planning, conducting and reporting all types of quality assurance audits
• Possess auditing experience in the USA
• Have excellent knowledge of ICH GCP guidelines, FDA/EMA regulations, and applicable local regulations
• Be team-oriented with superior communication and interpersonal skills
• Possess strong time management, organizational, planning and presentation skills
• Demonstrate the ability to meet tight deadlines, multi-task/be flexible and thrive in a fast-paced work environment
• Have intermediate proficiency in MS Office (Word, Excel PowerPoint, Outlook)
• Be a reasonably effective public speaker

Responsibilities

• Participate in QM resource allocation
• Allocate resources for QA auditors
• Facilitate professional development and career advancement of Quality Management staff
• Provide administrative supervision of Quality Management staff, jointly with Senior Director Quality Management
• Participate in recruitment of Quality Management (QM) staff
• Facilitate initial and ongoing training of Quality Management staff
• Oversee initial and ongoing training of PSI Operations employees in quality management topics
• Facilitate regulatory agency inspections of PSI
• Facilitate regulatory agency inspections of PSI-managed trial sites, including follow-up
• Participate in hosting client/third party audits of PSI, including follow-up
• Oversee CAPA investigations management
• Manage investigations of suspected research misconduct, jointly with Senior Director Quality Management
• Provide backup responsibility for review of draft Quality Systems Documents (QSDs), including newly developed and revised QSDs
• Provide backup responsibility for approval of Quality Systems Documents
• Oversee vendor qualification
• Oversee computer systems validation documentation review
• Oversee the process of providing assistance and feedback to all Company staff with regards to various GXP, regulatory compliance, and other QM matters
• Act as the primary QM contact for PSI Operations divisions and working groups/task forces with regard to various Corporate projects requiring QM
• Develop and implement the annual audit plan
• Manage QA audits contracted to PSI
• Oversee the preparation and maintenance of internal and contracted quality assurance audits documentation
• Be recruited by Business Development for client meetings and vendor shows

Preferred Qualifications

Possess an MD, PharmD or degree in life sciences