Job Summary

Leadership responsibility to manage quality assurance and compliance programs and business excellence efforts in TCG GreenChem. Represent as in house worldwide expert in cGMP regulations and understanding phase appropriate development requirements in drug substance development process. Assist in overseeing TCGLS practices assuring implementation and achievement of company strategic objectives with respect to the QA system. Take company responsibility and represent TCG GreenChemfor all clients’ QA and regulatory requirements. Develop and implement quality management systems, which enable operational excellence.

Principal Duties

1.Overall responsibility in establishment and improvement of the cGMP compliance in TCG GreenChem:
a.Interpret company guidelines and guidance of FDA, EMEA and relevant regulatory agencies for the company.
b.Establish and update cGMP standard and guidance to API development process up to Phase I including material handling and documentation requirement and understanding NCE development processes and commercialization process.
c.Advocate for improvement, simplification of cGMP compliance and harmonization with TCG GreenChem and industrial practices.
d.Overall responsibility in establishment, management and enforcement of company SOPs:
i.Establish and implement the scope of SOPs and framework of SOP structural system.
ii.Develop, implement and monitor SOP management mechanism to address: revision and review cycle, updating, consolidation /simplification.
2.Overall responsibility to establish and implement company training programs regarding cGMP:
a.Training programs for new hires, new supervisors to work in research lab and / or GMP environment.
b.Training requirements for specific job functions such as key team member and senior management job.
c.Monitor and evaluation of training programs
3.Overall responsibility in managing the validation activities to qualify facility and equipment for GMP application:
a.Develop scope and road map for validation process consistent with TCG GreenChem guidance and cGMP requirement
b.Define documentation requirement and individual responsibility of each participant
c.Develop a generic template or guidance for general validation process
4.Manage TCG GreenChem business process to optimize and improve overall workflow and update operational procedures and guidelines
5.Identify and educate appropriate key managers for maintaining the information system.
6.Timely, proactively and creatively address audit /inspection findings, feedbacks and suggestions to streamline, simplify and enhance compliance programs.
7.Implement appropriate compliance practice and concept with the basis of risk analysis and business ramification

Job Qualifications

• PhD or MS in analytical or organic chemistry and 15+ years relevant experience preferably in API development and scale up / manufacturing, orat least 10+ years leadership position to enforce cGMP compliance and regulatory affairs
• Thorough knowledge of FDA, ICH, EMEA, OSHA, EPA, CT DEP and guidance of relevant agencies
• Demonstrated a track record of success to interpret and apply cGMP regulatory requirements for API development process
• Demonstrated track record of success in establishment and streamline of cGMP training programs
• Track record of success in recruiting, mentoring and leading teams of multiple functions, to achieve compliance objectives
• Must be able to swiftly make critical decision and write investigational report, protocol, memo and drafts of compliance matters
• Exceptional communication skill in writing and verbal, able to negotiate and persuade. Demonstrated skill and ability to work on international team and committee

Skills Required

• Excellent verbal and written communication
• Critical thinking
• Problem solving
• Active listening
• Out-of-the-box thinking
• Proactivity
• Knowledge of technology trends
• Knowledge of regulatory requirements