Quality Assurance Manager M/F (28321)

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

1. Honk Kong Affiliate functions:
   • Quality Responsible Person of Hong Kong Local affiliate

• • Be the Person-in-charge for the Wholesale Dealer License of the company
  • Lead and manage the Quality Management System of Hong Kong  local Affiliate    

• Manage Return, complaint, deviation and track closure and efficiency of CAPAs
• Deliver GDP training and conduct self-inspection.
• Ensure that equipment and area used for distribution are correctly qualified.
  • Administer/monitor all local Standard Operating procedures (SOPs)/Work Instruction (Wis) /Records.
  • Ensure the warehouse operation is compliant with the local requirements of health authorities and Global Policies
  • Ensure the local procedures are in line with Global Policies & Guidelines and current regulatory requirements.
  • Performs local release of inbound and repackaged products, in compliance with the applicable regulations and relevant regulatory directives.
  • Apply a Quality Risk Management approach in addressing quality issues in the local affiliate, utilize risk management tools to identify and mitigate quality and compliance risks.
  • Establish and monitor Quality goals and metrics.
  • Participate in quality improvements projects.
  • Monitor contractors' quality and performance.
  • Perform qualification of the equipment and process related to GMP/GDP.
  • Ensure the Good Distribution Practices and the Guerbet Corporate Policies are applied and understood in the country
  • Manage HA inspection and support corporate audit, and, develop appropriate action to improve quality.
  • Report any issues or improvement opportunities to APAC/Global Quality Distribution Manager
  • Ensure Corporate products holds, safety alerts and recalls are correctly managed according to the local regulation and Corporate directive
  • Ensure the local Third Parties Logistic are correctly certified according to the local regulation and corporate policies (audit, quality agreement, quality meeting, KPI …)

• • Manage the outsourced secondary packaging operation

• •  Ensure the secondary packaging operation is compliant with the local requirements of health authorities and Global Policies
  • Establish Quality Agreements and Audits (Scope: Secondary packaging operations & Raw materials suppliers)
  •  Coordinate and issue Change Control to Secondary Packaging service provider
  • Master the packaging materials specifications.
  • Develop packaging materials with Regulatory and Vendor.
  • Manage packaging materials, BOM and quality decisions of goods with ERP system

2. REGIONAL (APAC) Quality Distribution:
   • To support the management of quality related processes related to TPL and distributors (e.g. return, temperature controlled monitoring, lane qualifications and risk assessment…) or transport (damaged, temperature excursion, deviation, …)
   • Support TPL, DCs etc certification process:
     • Audit and support audit of TPL, distributors, carriers etc.
     • Support the establishment of Quality Agreements
     • Establish Risk Assessment when requested

• • Implement quality councils for TPL, carriers and distributors
  • Continuous Improvements:
    • Support and/or lead projects assigned by manager

Education

• Bachelor’s degree in Pharmacy
• Holder of Pharmacist License issued by Hong Kong Health Authority
• Knowledge and skills typically acquired through 4+ years of experience in GMP, Pharmaceutical Distribution and/or Quality.
• Have proven knowledge of Pharma GMPS, GDP, Medical Device regulations, ISO and other international standards
• Solid experience in developing quality management plans
• Experience with SOP and training implementation
• Experience in managing multiple complex projects

• Preferred Skills: 
  • Excellent verbal and written communication skills in English and Chinese is required (Mandarin & Cantonese). Ability to write reports, and required documentations.
  • Ability to communicate information with courtesy and tact
  • Highly self-motivated
  • Strong organizational & Presentation skills
  • Flexibility
  • Initiative and mature judgement
  • Experiences from developing and deploying improvement concepts and leading improvement projects across cultures and regions.
  • Knowledge of theories, tools and practices in quality improvement & change management
  • Strong analytical and systemic problem solving skills.
  • Clear passion to develop and change self and others.
  • High personal integrity
  • Experience in computer applications such as SAP, Microsoft Word, Excel, Access and Power Point.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
  • Ability to interpret Quality standards for implementation and review
  • Demonstrated leadership and execution of Quality operations and processes.
  • Ability to make sound decisions about scheduling, allocation of resources and managing priorities
  • Demonstrated experience in working with multifunctional and multi-cultural teams.

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.