Quality Assurance Responsible

Quality Assurance Expert (Non Drug) - Sanofi - Budapest

Key accountabilities :

The Quality Assurance Manager (Non Drug) ensures active Quality management of contract manufacturing organizations and related Non Drug products assigned to them. This will be in line with current GxPs, applicable regulations, and company requirements providing Quality leadership and oversight to the organization, interfaces and network. The QAM acts as Quality responsible person and the first escalation to resolve Quality issues within scope promptly and to minimize the risk to Sanofi.

Duties

• Ensures that an appropriate Quality oversight of Contract Manufacturing Organizations (CMOs) and sub-contractors in the scope of responsibility, including appropriate Quality agreements and audits, is in place
• Guarantees compliance with GxP, applicable regulations and corporate requirements for all regulated activities
• Delivers against key Quality KPIs/metrics and drives results that ensure site compliance on a consistent and continuous basis
• Ensures identification, assessment, control and communication of risks involving components, raw materials, finished pharmaceuticals, within scope of responsibility
• Ensures the deviation and change control activities are consistently and timely managed
• Ensures implementation and evaluation of corrective and preventive actions to address systemic issues
• Support definition and implementation self-evaluation and continuous improvement tools
• Support set up and roll out Quality culture

The QAM will also support business units in the assigned region in the management of new business opportunities, product launches as well as in setting up Quality relevant contracts

Background and experiences :

• Advanced Degree (Master) in a science/health field (e.g., Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalent
• At least 2 years of work experience in Quality Assurance, Quality Control and/or Production
• Should demonstrate flexibility, proactivity and be able to communicate efficiently with various stakeholders internally and externally
• Should demonstrate solid oral communication and writing skills in an international environment
• Fluent in English

When joining our team, you will experience:

• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
• An attractive, market-oriented salary and cafeteria benefits
• Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days
• Work from an "Office of the Year 2020" finalist office
• Collective life and accident insurance
• Yearly medical check-up
• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks
• Your own career path within Sanofi. Your professional and personal development will be supported purposefully
• Practice your language skills within our "Language Club"
• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, gender identity or Veteran status.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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#PursueProgress

#DiscoverExtraordinary

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.