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Senior Quality Consultant

 

 

The candidate will need be familiar with CFDA and EU/US regulations and international industrial best practices, to lead in getting through the international and national GMP, GSP and ISO 9001 assessment and other regulatory authority assessment, to implement document control effectively, to plan and monitor the GMP training and internal audit, to qualify and monitor the External Manufacturer and contractor to ensure full compliance with GMP, GSP and all related regulatory requirements.

 

Your role:

  • Project work in all project sizes and phases as per business needs;
  • Solve tasks independently, to the highest degree of complexity;
  • Ensure interfaces to and coordination with other disciplines.
  • Ensure changes to the scope of work are brought to the attention of the project management.
  • Be able for generating, maintaining and improving Quality Management System (QMS) including policy/standard, SOP and working instruction, etc.
  • Introduces, interprets, reviews and ensures the full implementation of regulations and guidance documents from international and national regulatory authorities. Assesses compliance risk and recommends corrective action.
  • Be able for readiness preparation for GMP, GSP, ISO9001 and other quality system inspections, and other quality system inspections by executing readiness plan.
  • Plans and leads internal audit to identify gaps and provide recommendation for solutions.
  • Establishes and manages quality management systems, e.g. Deviation, CAPA and Change Control process;
  • Be able to monitor the progress to ensures the on time closure and submission of execution summary to operation committee.
  • Be able to audit External suppliers, manufacturers and contractors.
  • Draft and negotiate the Quality Agreement based on newest regulations if necessary
  • Monitor contractors, implement quality audit and follow up CAPA

 

Who you are:

Education and Languages:

  • Bachelor in life sciences or related science/engineering background with a strong emphasis in biologics.
  • Fluent in Chinese & English (written) is required.

 

Professional Skills and Experiences:

  • Minimum of 8 years of relevant quality experience in biopharmaceutical companies or consultancy companies. 2+ years of practical QMS experience is preferred.
  • Knowledgeable of CFDA pharmaceutical regulations and regulatory landscape of other important country/regions (eg. China, Japan, South Korea, EU, US)
  • Proven knowledge of cGMP, FDA, EMA, ISO 9001 standards, international industrial best practice and guidance, regulatory and compliance requirements, aseptic processing.
  • Knowledge/experience for regulations regarding complex biologics (i.e., monoclonal antibodies and recombinant proteins, novel therapy) expressed in mammalian cell culture.
  • Experience working in a global, matrix environment.

 

Personal Skills and Competencies:

  • Strong organizational and time management skills.
  • Good project management skills.
  • Able and willing to travel frequently(Could work and relocate on project site for more than 3 months based on project needs)
  • Ability to train and educate others.
  • Effective management by influence.
  • Ability to work in multi-cultural teams.
  • Good listening skills with the ability to analyze and respond to given situations quickly and effectively.
  • Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels.
  • Ability to indirectly influence other organizations and cultures.
  • Proficient in MS Office Software (Word, Excel, PowerPoint, Project).

 

Functional Area: Regulatory & Medical Affairs

Job Requisition ID:  194035
Location:  Shanghai - all
Career Level:  E - Professional (10+ years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Job Segment: Medical, CAPA, Quality Manager, Pharmaceutical, Quality, Healthcare, Management, Science

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