Clinical Operations and Regulatory Affairs, Shanghai | 4 Oct 2021
QA Senior Manager / Manager, Analytical
Job Title:
QA Senior Manager / Manager, Analytical
Location:
Shanghai
COMPETENCIES; Knowledge, Skills and Abilities
Must have a strong Quality Control mind-set with extensive knowledge and experience of cGMP operations as well as general industry (ICH, USP, etc.) and health authority (NMPA, FDA, EMA, PMDA, etc.) requirements for medicinal Drug Product.
Knowledge of risk management principles and their implementation into routine production and/or testing strategies.
Must be able to interpret problems and effectively communicate in a productive manner to management and teams.
Must be able to evaluate technical/scientific attributes and drive compliant technical decisions under minimal supervision.
Must have strong troubleshooting skills and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality requirements.
Must have strong hand-on solid dosage QC testing/operation experience that could immediately form a preliminary decision for an OOS that might trigger a Field Alert Report.
Must have strong experience of the OOS investigation.
Must have strong experience for the method validation and transfer
Must be fluent in both Chinese and English.
Duties and Responsibilities
Oversee and perform cross-functional QC laboratory assessments and implement improvements to assure Hutch-Med QC expectations would be fulfilled.
Collaborate with individual CMO QC team and individual cross functions (i.e. Analytical Development, Process, Formulation) to support strategies for improvement and implementation of best practices and automation.
Responsible for handling the analytical related issues like OOS result at CMO for commercial product in a timely manner and make a quick proposal to management team if marketed product is impacted.
In charge of the analytical method, specification, stability study, retain sample management for commercial products.
Lead the Product Quality/Analytical QA team to provide daily oversight on the good compliance of analytical document at Hutch-Med and its CMOs;
Provide product quality inputs to quality events, like product complaints.
Participate in the project CMC programing from analytical compliance perspective.
Develop product quality/analytical team members from both technical and soft skill perspective
Education and Experience
Bachelors’ degree in analytical chemistry and/or Pharmacy
Masters and above Degree preferred
Minimum of 7+ years of Pharma industry experience in a QC or QA role(s) supporting programs in pre-clinical phases through commercial, with at least two years management role
Strong project management skills and ability to communicate effectively across matrix functions
Excellent verbal and written English communication skills