JOB DESCRIPTION

JOB DESCRIPTION: Director QA Operations
Current Version: 30APR24
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JOB TITLE: Director QA Operations	JOBCODE: O05M4<br>FLSA: Exempt
DIVISION/SITE: MEMPHISCOG
DEPARTMENT: Quality Operations
REPORTS TO: Sr. Director or Vice President of Quality Memphis
ORIGINAL DATE: 14-JUL-2020	LAST REVISED: 4-AUG-2023

BASIC 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 for overseeing 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 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."

JOB DESCRIPTION: Director QA Operations
Current Version: 30APR24
Page 2 of 4

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.
Perform all other related duties as assigned.

QUALIFICATIONS:

Minimum BS/BA Life Sciences or related field. An advanced degree in the life sciences is preferred, but not essential, based on experience
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
Ability to maintain a high degree of accuracy and attention to detail.
Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively.
Demonstrated project management skills
Demonstrated management and collaboration skills
Outstanding verbal and written communication skills.
Complete competency with electronic document managements systems and other information management systems
Proficiency in Microsoft Office (Word, Excel, Outlook, etc.) is essential.

PHYSICAL DEMANDS:

	NEVER	OCCASIONALLY<br>.25-2.5 DAILY HRS	FREQUENTLY<br>2.5-5.5 DAILY HRS
SIT			✓
STAND			✓
LIFT/CARRY:	INDICATE AMOUNT/FREQUENCY BELOW
0-10 LB		✓

JOB DESCRIPTION: Director QA Operations
Current Version: 30APR24
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	NEVER	OCCASIONALLY<br>.25-2.5 DAILY HRS	FREQUENTLY<br>2.5-5.5 DAILY HRS	CONTINUOUSLY<br>5.5-8 DAILY HRS
10-20 LB		✓
20-50 LB		✓
50-100 LB	✓
OVER 100 LB	✓
WALK			✓
DRIVE	✓
REACH ABOVE		✓
BEND/STOOP		✓
USE HANDS FOR:	INDICATE ACTIVITY/FREQUENCY BELOW
PUSHING/PULLING		✓
FINE MANIPULATION		✓
STRESS LEVEL	LOW	MODERATE	HIGH	VERY HIGH
		✓

All employees are required to satisfactorily perform the essential duties and responsibilities of their position. • The essential duties and responsibilities listed above are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

Job Description Acknowledgement Form

JOB DESCRIPTION: Director QA Operations
Current Version: 30APR24
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I, ___________________________________________________ acknowledge by my signature below that I
have
(Employee Name)

reviewed and received a copy of my position description. I have read and
understand my job duties and responsibilities.

I further understand that I am responsible for the satisfactory execution of all the duties
described therein, under any and all conditions as described.

___________________________________________ _______________
Employee Signature Date