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Director of Quality Assurance


Function:
 Quality Assurance

 

Location:  Shanghai

 

Reporting line:  CEO

 

Job description

 

As QA director of Laekna therapeutics, this role will be responsible for all quality related activities for both DS and DP to support Laekna’s pipeline products at different stages ranging from preclinical, clinical, and commercialization. He/she will oversee all quality related activities through active coordination and communication internally and externally to meet project timeline. He/she will be responsible for defining overall quality strategies for Laekna’s R&D and manufacturing activities and final release of Laekna’s product for clinical studies.

Major responsibilities

1.    1. Responsible for defining quality strategies to ensure Laekna’s R&D and manufacturing activities within compliance to relevant regulatory guidelines

2.    2. Responsible for oversee quality related activities through active coordination and communication internally and externally to meet project timeline

3.    3. Responsible for final release of Laekna’s product for clinical studies

4.    4. Maintain robust quality management system to support Laekna’s product development

5.    5. Responsible for internal quality capability buildup to support potential Laekna’s manufacturing facilities

Requirements

1.    1. BS with over 10 years or MS with over 8 years working experience in big pharm or biotech companies in quality management functions for various positions including quality system, vendor management, manufacturing, analytical, etc.

2.    2. Familiar with regulatory CMC requirements for FDA/EMA/CFDA and have rich experiences in DS/DP manufacturing and release to support clinical development.

3.    3. Strong leadership and excellent management skills to oversee multiple projects for fast progress and timely communication with upper management and relevant parties.

4.    4. Self-driven initiative and strong willing to work in startup environment to learn, share, and grow.

 

 

About Laekna Therapeutics

Founded in December 2016, Laekna Therapeutics is a startup biotech company focusing on innovative drug discovery and development. Motivated by the high unmet medical needs of the patients, we are dedicated to developing new targeted therapies to treat cancer and liver diseases. Laekna has strong expertise in both small molecule and antibody discovery and development. Our CEO, Dr. Chris Lu, and the leadership team all have extensive R&D and management experience in global pharmaceutical companies, along with an exceptional track record of new drug approval and marketing. Laekna is a young company full of energy and innovation. Our talented scientists are striving to solve the biggest problems in healthcare and to bring breakthrough medicines to patients.