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:

• BA/BS and a minimum of 10 years’ experience working in the pharmaceutical industry in a quality role with at least 3 years of management experience/direct supervision of staff.
• Broad knowledge of GXPs (CFR/ICH) and applicable international regulations and guidelines.
• Quality Assurance experience in the oversight of both clinical and commercial operations.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Good problem-solving skills, a keen attention to detail, ability to work independently and be able to effectively manage multiple priorities.
• Previous experience in preparing for and hosting/responding to regulatory health authority inspections.
• Strong interpersonal and organizational skills and excellent verbal and written communication skills are required. 
• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
• Proven ability to author, understand and follow complex written procedures.
• Successful record of creating and managing complex project plans, timelines, budgets, and critical paths.
• Previous management experience with the ability to effectively manage performance, engage team members, provide coaching, implement improvements, and respond to situations affecting staff.
• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
• Must be able to travel up to 10% of the time for both domestic and international business.