|Job title :||Head of QA|
|Location :||Milano, Milan (province)|
|Job type :||Permanent|
|Contact name :||John Swift|
|Contact email :||firstname.lastname@example.org|
I am working with a fantastic Oncology focused company who are seeking a Head of Quality Assurance with a focus on GCP QA for their office in Italy.
An overview of the position is below;
The Head of Quality Assurance will report to the CEO and will be responsible for implementing and leading all Quality programs and assuring compliance with all relevant local and international quality and industry regulatory guidelines as they pertain to company product candidates and medicinal product development processes. The Head of Quality Assurance oversees that functional departments and project teams implement systems and processes that meet applicable legal, regulatory and ethical obligations and standards.
The requirements are as follows;
*12+ years of experience in Quality Assurance at management level, leading quality assurance in a pharmaceutical or biotech environment.
*Experience contributing to and reviewing regulatory filings with regard to compliance and quality requirements and aspects.
*Experience with oncology therapies and fully understanding of FDA and EU guidance documents and requirements.
*In-depth knowledge of pharmaceutical GCP, GVP (Good Pharmacovigilance Practice) and CSV (Computerized Systems Validation) and understanding of applicable GxP (US and EU) and ISO guidelines.
*Prior experience implementing quality systems and advancing novel therapeutics from preclinical stages through IND to NDA/BLA is desired.
*Effectively manage FDA/EU inspections/audits and conducted vendors audits.
*Must have excellent verbal, written, and interpersonal communication and presentation skills in English, working command of oral Italian is preferred.
*Demonstrated ability to manage staff and projects (direct and indirectly) and variable workloads with demanding timelines.
Please contact me on email@example.com for a full job spec and more information.