Global R&D QA, R&D Quality Biotech Manager
Parma, IT
About us
Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.
At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.
Chiesi Research & Development
Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).
Who we are looking for
This is what you will do
Guarantee the compliance with EU and US regulations related to the application of the Good Manufacturing Practices for gene editing and biological products for clinical trials.
You will be responsible for
- QA GMP reference in Project Teams related to gene editing/biological products for clinical trials
- QA oversight on quality documentation (review and approval of master batch record, executed batch record) related to the project assigned
- QC oversight on external suppliers (method development and validation, specification setting for different clinical phases)
- Management of change, OOS, deviation, Temperature excursions
- Review and approval of GMP protocol and report (Technology transfer, Process validation, method validation, stability, etc.)
- Clinical Trials Supplies complaint management
- Quality Agreement review for the relevant sections in relation to the projects assigned
- Drafting, revision and harmonization of Standard Operating Procedure
- Training execution on the Standard Operating Procedure
You will need to have
- Experience in Quality Assurance, Quality Control or production in Gene editing/Biotech/Biopharmaceutical companies of at least 5 years.
- Degree in Biology or Biotechnology.
- Proficient in spoken and written English.
- Knowledge of the EU-GMP, CFR 21 part 210-211 and 600, ICH in the field of pharmaceutical development
- Knowledge of the process of drug development
- Knowledge of drug product manufacturing processes, in particular sterile/aseptic/lyophilization processes applied to gene editing/biological products
- Knowledge of MCB and drug substance manufacturing processes
- Knowledge of analytical/bioanalytical techniques
- Knowledge of ERP and EDMS
We would prefer for you to have
- Planning and organization skills
- Team working
- Decision making ability
- Independence in judgment and objectiveness
Location
Based in Parma, with the possibility of a hybrid working arrangement.
What we offer
No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.
We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.
Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.
Screen readers cannot read the following searchable map.
Follow this link to reach our Job Search page to search for available jobs in a more accessible format.