Oxygen Biotherapeutics, Inc. is composed of a dynamic group of highly educated and talented individuals that direct their divergent skills and experiences to the business of creating, developing and marketing topical and intravenous products focused on delivering oxygen to tissue. We have created an entrepreneurial environment to challenge our employee's intellectual and creative abilities. We recruit highly motivated, energetic individuals who are seeking new opportunities to actively contribute to the growth and success of our company.

Position Available:

JOB TITLE: Manager, Quality Assurance and Regulatory Compliance
BASED AT: Corporate Headquarters, North Carolina

JOB PURPOSE: Responsible for developing and maintaining the company's Quality Assurance and Regulatory Compliance program (QARC). Areas of responsibility include, Clinical Compliance (GCP), Laboratory Compliance (GLP/GMP), Document Control and training administration programs.

KEY RESPONSIBILITIES AND ACCOUNTABILITIES

1. Establish and enforce standard Quality practices for the manufacture and release of products.

2. Generate and maintain standard operating procedures, protocols, qualification and validation documents, chain of custody, and any other documentation necessary for regulatory compliance.

3. Responsible for conducting, or organizing resources needed to conduct,

a. internal and external audits and reviews
b. support regulatory agency inspections
c. administration of procedural documents
d. quality oversight of R&D and external manufacturing

4. Establish standard of quality for product manufacturing conducted by third party vendors.

5. Responsible for ensuring adequate procedures are in place for identifying, defining and directing activities of consultants involved in providing services subject to quality and/or regulatory compliance requirements.

6. Responsible for ensuring all staff are aware of applicable compliance requirements and responsibilities.

7. Responsible for maintaining document control system.
8. Foster a commitment to quality in individuals and a culture of quality within the organization.

9. Ensure coordination of audit follow-up and corrective action planning with appropriate functional areas.

10. Responsible for ensuring implementation of required corrective actions.

11. Ensure the preparations for, and management of, regulatory agency inspections (domestic and international). Ensure appropriate responses are prepared to any regulatory agency findings and are communicated in a timely manner.

12. Ensure that annual training plans are in place supporting needs of the organization and changes in regulatory requirements.

JOB DESCRIPTION

• Product manufacturing Quality Control and release

INTERNAL CONTROL RESPONSIBILITIES

• Designated Quality Assurance Manager under FDA requirements

• Establish and manage controlled document system.

• Establish and maintain personnel training system

• Excellent verbal and written communication skills and demonstration of excellent interpersonal skills.

PERSONAL CHARACTERISTICS

• Must be well versed in regulatory requirements, including GCP/GLP/GMP and ICH requirements and have an astute understanding of current global and regional trends in regulatory compliance and ability to assess the impact of these requirements on the business.

• Demonstrated understanding of business needs and changing regulatory environment.

• Excellent organization skills and ability to ensure a multitude of tasks are appropriately delegated, managed and completed.

• Demonstrated ability to lead teams of people from diverse backgrounds in development of systems and procedures and implementation of corrective actions.

• Demonstrated creative approach to solving problems.

• Ability to work autonomously and reliably towards corporate regulatory and quality goals.

• Able to inspire confidence within the Company as an expert in regulatory and quality assurance compliance.

EDUCATION AND EXPERIENCE

• Requires a minimum of BS degree (or equivalent) in a scientific discipline with at least 8 years of related experience in pharmaceutical quality assurance, compliance and regulatory disciplines, or MS degree with 5 years of experience. (Minimum requirements to fill the position)

• Experience in cosmetic manufacturing preferred but not required.

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