Director Quality Assurance Operations

Job Summary

POSITION SUMMARY
This position reports to the Sr. Director or Vice President of Quality (Memphis), and will be responsible for the development, implementation and improvement of quality operations and regulatory interactions with all manner of national and international regulatory authorities for any client or local concerns relating to the Memphis Manufacturing Operations. This position interacts regularly with key clients. This position is responsible to oversee all quality operations functions, including lot disposition, deviation and CAPA disposition, quality on the floor activities, hosting client and regulatory audits including responses and continuous improvements. This position will provide the appropriate leadership and strategic direction to operate and maintain a regulatory compliance position in support of existing and new cellular therapy production. Serves as a site host during regulatory inspections and regularly communicates with all local, national, and international regulatory agencies. This position will also oversee timely batch lot disposition, timely investigation and CAPA related to deviations. This position will also oversee the development and presentation of all quality Management Review metrics and site risk assessment.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

Conceptualize, create and develop all Quality Operations strategy and tactics for the Memphis Manufacturing Operations, in collaboration with other Quality Assurance groups and Manufacturing.

Develop and oversee the quality on the floor operations, including timely identification of deviations and corrective actions, timely lot disposition, line clearances and in-place continuous audits.

Advise the Head of Quality of necessary regulatory changes and updates to regulatory and compliance approaches.

Develop and execute training and Management briefings at any technical or compliance level required on updates and regulatory requirements for Cell and Gene Therapy manufacturing and controls.

Manage the implementation, maintenance, and improvement of all lot disposition functions.

Regularly communicate with clients and participate in the Client quality reviews and other steering committees as required.

Act as the acting Head of Quality as needed or assigned.

Develop metrics and run the Quality Management Review process for clients and Memphis Operations.

Review and comment on any CMC regulatory filings for clients.

Review/ approve the Firm’s “drug master file.”

Review/ approve/ update the Firm’s “site master file.”

Perform any client label approvals.

Coordinate and publish any correspondence with Regulatory Agencies.

Represent Quality department during regulatory inspections, client audits, and various cross-functional meetings, as needed.

Participate in the Company GMP Training Programs, including new employee orientation and periodic GMP retraining and selected topics.

Oversee the Company quality management system deployment and monitoring including client metrics, effective deviation investigation and effective CAPA.

Oversee the Visual Inspection Program and Packaging Inspection Manufacturing

Oversee the Incoming Receipt and Inspection program for components and raw materials

Oversee the writing update of most GMP Company documents, including batch record development and deployment, label generation, work orders, validation protocols/ reports and standard operating procedure updates.

Demonstrate an employee-focused leadership style that prioritizes compliance, respectful and professional cross departmental collaboration, accountability, and the well-being, personal, and career development of each employee.

Job Qualifications

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS

• Demonstrated management and collaboration skills
• Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively.
• Ability to maintain a high degree of accuracy and attention to detail.
• Outstanding verbal and written communication skills.
• Minimum 10 years of experience in a biologics, pharmaceutical, medical device, or related industry. 15 years experience is preferred
• Previous experience in Cell and Gene Therapy is desirable, but not a require per say, if other experience in the regulated life sciences
• Complete competency with electronic document managements systems and other information management system
• Demonstrated project management skills
• Minimum BS/BA Life Sciences or related field. An advanced degree in the life sciences is preferred, but not essential, based on experience

Compensation Data

The pay range for this position is $200,000/yr - $220,000/yr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Competencies