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Global R&D QA, R&D Quality Biotech Manager
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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 forQA 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.
Equal Opportunity Employer 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.
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