Sr. Director/ Head of Quality Assurance

JOB SUMMARY :

The Sr. Director / Head of Quality Assurance will be responsible for overseeing the GxP Quality Management System for clinical research and commercial operations. This position is responsible for providing Quality and Compliance expertise and support and leading process improvement initiatives.

This is a hybrid role with 1-3 days on site at the corporate offices in San Diego, CA.

ESSENTIAL DUTIES & RESPONSIBILITIES :

• Establish, manage, and monitor the Quality Management System in accordance with applicable regulatory requirements to ensure its continuing suitability, adequacy, and effectiveness, including assessments of opportunities for improvement and need for changes.
• Manage the company training program for assessment of training requirements to ensure that staff is trained in procedures that support their job responsibilities and the operations of the Quality Management System.
• Manage the audit program to include establishing and approving an annual schedule, conducting audits, overseeing contract auditors, and performing follow up on corrective and preventive actions.
• Manage the effective operation of the document control system and maintenance of the relevant records and ensure all documentation pertaining to processes and procedures are reviewed as needed to ensure they reflect current practices.
• Manage the investigation reports of product quality issues and ensure resolution in accordance with company procedures and regulatory requirements.
• Lead efforts and provide guidance and assistance with the development and review of new Quality Agreements to support GMP and GCP vendor oversight.
• Work closely with members of the executive team to facilitate product registration and commercialization.
• Contribute to the development of the Quality Assurance function by introducing and driving positive change with the oversight of new initiatives, systems or directives for ongoing process improvement and implementation of best practices.
• Review regulatory documents and provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance.
• Assist with the preparation of, and participation in regulatory inspections and lead the efforts for timely responses to inspection results.

EDUCATION AND EXPERIENCE :

KNOWLEDGE, SKILLS, AND ABILITIES :

At ARS, we are proud to offer a highly competitive compensation & benefits package.

The full-time salary range for this posted position is $240,000 to $260,000 and may be eligible for a discretionary annual performance bonus. Actual pay rates are determined by considering multiple factors including qualifications, relevance of experience, education & credentials, subject matter expertise, and other job-related factors permitted by law.

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Salary : $240,000 - $260,000