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Date:  Jan 28, 2023
Location: 

Shanghai (CHN), CN

Job Type:  Long-term/regular

 Supplier Quality Manager M/F (26986)

 

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

 

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

 

Achieve, Cooperate, Care and Innovate are the values ​​that we share and practice on a daily basis.

 

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

 

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

 

Representing the Guerbet Quality Technical Operations organization in oversight and monitoring of the GMP development and production in API & Starting Material manufacturing sites of Guerbet suppliers to ensure product specifications are met. Additionally, responsible to review data related to product quality, efficacy, safety and support investigations.

The CSQM will challenge and influence the supplier to improve their Quality compliance culture. He / She will assist the supplier in API & SM development phases and he / she will conduct site audits and will , personally observe batch manufacturing activities.

In essence, the CSQM will serve as the project sponsor’s eyes and ears at the contract site. He / she will be expected to identify current and future risks to Guerbet and be the Guerbet lead on ensuring those risks are addressed by the supplier.

The CSQM will first focus on GMP Development activities and then transition to GMP Production activities.

 

ESSENTIAL DUTIES & RESPONSIBILIITES:

Step 1: GMP Development activities

  • Assist the supplier in API & SM development phases
    • Monitors (and provides as needed guidances to the supplier) Validation and Qualification activities
    • Coordinates all Guerbet functions involved in the project (process development, manufacturing, quality control, regulatory affairs…) and acts as the primary Guerbet interface with the Supplier
    • Ensures the achievement of the Supplier project objectives (quality, costs, deadlines, customer satisfaction, regulatory) and monitors supplier project status to make sure everything stays on track
    • Anticipates changes & risks and identifies appropriate actions
    • Provide guidance to the supplier on the level of documentation needed for Marketing Authorisation changes.
    • Ensures API manufacturers are compliance ready for regulatory visits / inspections at European and US regulatory standards.
    • Collaborates closely and aligns with the supplier at all stages

Step 2: GMP Manufacturing activities

  • Drives, leads, and troubleshoots quality investigations at API/Starting Materials suppliers to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions.
  • Quality review of documents from API/Starting Materials manufactures for compliance with Guerbet policies and procedures.
  • Ensure quality checks on on-going operations at API/Starting Materials manufacturers for:
  • Oversight of physical product quality for the Raw Materials, API/Starting Materials Manufacturing, Packaging & Labeling operations and Materials Control.
  • Follow-up Good Documentation Practices.
  • Adherence to approved Batch Record instructions & final release of manufactured products.
  • Support troubleshoots product quality defects and AQL failures
  • Identify, design, and propose process and systems improvements.
  • Manage competing priorities and allocate resources to meet targets and timeline.

General

  • Implement and monitor Guerbet vendor management key performance indicators at contract manufacturers and present at the relevant Quality Review Meeting.
  • Provide audit support of Guerbet API/Starting Materials manufacturers as required.
  • Work with Guerbet Technical Operations personnel to identify technical and safety risks.
  • Report on Quality Cultural improvements needed at supplier site and throughout the supplier’s organisation.

 

REQUIREMENTS:

  • Requires a Bachelor’s degree in the sciences (e.g. biology, chemistry, analytical or bio-analytical chemistry, engineering) with a minimum of 10 years of API/pharmaceutical experience in a GMP quality (QA/QC) environment at European or US regulatory standards. An advanced degree in sciences and experience working with International Team would be a plus.
  • Strong working knowledge of ICH Q7 and ICH Q9 requirements and all CGMP’s including but not limited to Qualification / Validation of Equipments, utilities, processes, analytical methods, cleaning methods
  • Strong experience with leading and managing quality investigations.
  • Experience in managing contract manufacturing organizations and driving process improvements.
  • Strong auditing experience on contract manufacturing organizations & API/Starting Materials. Certified Quality Auditor would be a plus.
  • Strong leadership and negotiation skills. He / she must set a high standard and drive the supplier to achieve that standard while maintaining good working relationships.
  • Must have excellent verbal, written and interpersonal communication skills in both Chinese and English.
  • Knowledge of API Product Chemical Development and Regulatory requirements
  • Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and/or Failure Mode Effects Analysis (FMEA) is preferred).
  • A willingness to learn a basic level of technical engineering and process safety concepts that are applicable to an API synthesis site with hazardous chemicals.
  • Knowledge of Operational Excellence and data driven Root Cause Analysis.
  • Knowledge of good Data Integrity practices and regulatory requirements.
  • Position located in China – At API/Starting Materials supplier location (Region of Nanchang).

 

Reason to join US

Much more than a Competitive salary,


We offer continued personal development. When you join Guerbet, you :

  • Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, 
  • Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
  • Are joining a company where we value diversity of talents coming from various horizon.

 

We # Innovate # Cooperate # Care #Achieve at Guerbet. 

 

Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identify, and maintain employment statistics on applicants.

 

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on Guerbet. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process.

 

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com.