Job Description

Primary DUTIES AND RESPONSIBILITIES: 

Promotes a safe work environment

Develops and manages a daily plan for the Quality Assurance Operations shift, responsible for review and approval of documents/records, including executed batch records, standard operating procedures, material specifications, and validation protocols and reports. 

Supports end to end deviation management process.

Ensures the safety of the patients by adhering to company policies and procedures, and cGMP requirements.

May participate in cross functional project teams as a Quality representative.

Responsible for people management lifecycle including recruitment, development and performance management.

Identifies and mitigates risks in production, quality and supporting operations that could negatively impact the safety, identity, strength purity or quality of the product. 

Assists in the design, implementation and continuous improvement of Quality Systems. 

Actively pursues learning of required skills and new skills. 

Ensures team goals, site and corporate objectives are met. 

REQUIRED COMPETENCIES: 

Knowledge, Skills, and Abilities: 

Knowledge in electronic batch documentation systems is preferred,

Experience in deviation management systems and causal analysis tools desired.

Experience in aseptic processing and cleanroom environments is preferred.

Must exercise sound judgment and be able to critically evaluate available information to identify appropriate course of action in a timely manner.

Proven commitment to quality and continuous improvement. 

People management experience required.

Education and Experience:

Master’s degree in related field is preferred. Minimum of Bachelor’s degree and/or equivalent combination of education and experience is required.

7-10 years of relevant cGMP experience in FDA/EMA regulated environment

Experience in cellular therapy field is preferred. 

WORKING CONDITIONS (US Only): 

While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. 

Work in areas that may have strong magnets.  

May work in areas with exposure to vapor phase liquid nitrogen 

Must be able to obtain gowning qualification to enter a cleanroom environment  

May be required to work nights, weekends and holidays in a 10-hour shift structure. 

Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.