南京招聘

Responsibilities:

1. As a key leadership role, build and establish the Quality organization for existing cGMP manufacturing

site and new state of the art facility that is under construction. Provides Quality leadership in all cGMP

related areas of responsibility. Leads and ensures delivery for multiple departmental functions (Quality

Assurance, Quality Control, Quality Systems, Quality Validation etc).

2. Lead and host compliance audits and regulatory inspections by competent regulatory authorities

(FDA/EMEA/MHRA/CFDA etc.).

3. Lead Quality team to provide oversight for cGMP compliant manufacturing and robust supply chain for

cell therapy products.

4. Collaborate with other leaders across the organization and assist in the continuous improvement and

lifecycle management of GMP policies and Quality Management Systems, including providing guidance

and direction for transitioning from clinical to commercial phase GMP operations.

5. Drive a strong quality and continuous improvement culture within the organization, ensure that

standards for product quality, employee safety and housekeeping standards are maintained..

6. Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal

procedures to assure compliance at the manufacturing facilities.

7. Work collaboratively with leads from Facilities and Engineering, Manufacturing, IT, Supply Chain,

Operations, MS&T, to ensure the timely facility qualification and readiness for commercialization.

8. Accountable for Product Disposition for both Clinical and Commercial Product.

9. Establish and oversee the External Quality External organization responsible for oversight of critical

suppliers, CMOs, distribution network including patient apheresis and cold chain management.

10. Working in conjunction with Quality Systems organization deploy key Quality processes throughout the

Cell Therapy development and commercial organizations.

11. Build a strategy to develop existing talent through broadening experiences and commitment to delivery

to the highest standards. Continue to build bench strength in technical operations and ensure robust

succession planning.

Experience:

1. Minimally 18+ years of combined experience working in an aseptic manufacturing facility with QA,

manufacturing Compliance, clinical Quality and Quality Systems experience. Prior cell therapy and/or

Biologics experience preferred.

2. Experience with cGMP Manufacturing Practices in China, US.

3. Minimum of 5 years of experience in leadership role overseeing Quality GMP operations in a

commercial manufacturing facility is required.

4. Demonstrated Quality leadership through a partnership with manufacturing to enable high quality and

compliant product distribution to patients is required.

5. Demonstrated ability to build effective and efficient teams and drive change within an organization.

6. Experience in a growth environment managing the fast pace of change, balancing day to day Quality

including Quality Assurance, Quality Systems and Quality Control.

7. A history of developing and building cohesive, high performing teams with a strong sense of mission,

providing training and mentoring to build sufficient management depth throughout the organization and

ensure strong succession planning.

8. Communicates effectively with people at all levels, including the ability to understand their priorities,

and to earn their respect and trust, along with the willingness to provide them with the best decisions in

time-sensitive situations.

9. Capable of thriving in a fast-paced, challenging, entrepreneurial and team-oriented environment.

10. Excellent teamwork and interpersonal skills with ability to influence and build strong working

relationships at all levels.

传奇生物（NASDAQ: LEGN）是一家处于临床阶段的全球生物制药公司，专注于肿瘤和其他领域的新型细胞疗法的开发。目前，公司在中国、美国、欧洲拥有800多名员工。运用创新的技术手段、全球研发模式、生产策略和专业知识，公司具备强大的潜力为患者开发和制造一流的细胞疗法。传奇生物通过战略合作开发和商业化旗下主导产品西达基奥仑赛（cilta-cel），这是一种靶向BCMA的CAR-T细胞疗法用于治疗多发性***瘤患者，该药物目前正处于注册临床试验阶段。