Position Title: Sr. Quality & Regulatory Compliance Manager

Function: Quality Assurance 

Entity: Laekna Therapeutics (Shanghai)

Location: Shanghai

Job Summary:

Quality Assurance is to provide the quality strategic direction for a robust, sustainable and cost-effective plan to ensure that new products can reliably and in compliance be brought to market and supplied until their ultimate phase out.

You will work in a matrix team and with external CMOs and are responsible for driving the design and implementation of QMS under responsible area to mitigate the risks of patient safety, product quality, regulatory compliance, QMS compliance and data integrity to acceptable level. Ensure regulatory inspection readiness (internally and externally) at all the times and maintain licenses, if available.   

Responsibilities

1.Drive Laekna’s QMS establishment, implementation, and monitoring to ensure appropriate quality standard and procedures are applied:

• ● Responsible for alignment with stakeholders to drive new procedures required by GMP/GDP regulations are in place, in use and effective.
• ● Provide Quality oversight to QMS, identify and evaluate risks, issues and improvement opportunity, and then escalate the significant events to management teams, engage in deploy mitigation plan and track the status in a control manner.
• ● Establish and execute/support of the internal audit program.
• ● Manage the emerging regulations and systematic evaluation of new requirements, educate employees around new requirements, compliance trends.
• ● Support PAI and GMP/GDP inspection readiness program
• ● Responsible for training, including new employee GMP/GDP training, continuous and refresh training, regulatory compliance and audit training and quality process training.
• ● Responsible for documentation management and records retention.

2.Drive the improvement of performance of CMO’s QMS quality:

• ● Conduct audit to contractors against GMP/GDP standard, provide quality input into sourcing decisions.
• ● Routinely report product quality health status at CMO sites and drive mitigation actions, including deviations, out of specifications, events ect
• ● Monitor and evaluate contractor/supplier’ quality management periodically.

Qualifications:

• ● Minimal Bachelor’s degree in Pharmacy, Biology, Chemistry, or related fields.
• ● Minimum 10 years of experience working in pharmaceutical or biotechnology industry experience in a quality and GMP area.
• ● Comprehensive knowledge of regulatory agency interactions and compliance procedures, with ability to apply the knowledge in an operations environment and promote process improvement continuously.
• ● Solid knowledge of quality systems, audit or inspection management, risk assessment, and other evolving principles across the global compliance area.
• ● Good communication skills, strong quality minds and strong service minds.
• ● Continuously invest time and effort to gain new skills and knowledge required to succeed in the work.
• ● Good English and Computer skill.

Laekna is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.