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Sr. Quality Assurance Officer

3 mesi fa

Milano, Lombardia, Italia Allucent A tempo pieno

These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities.

You'll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you'll help make a positive difference in patients' lives.

Summary:

The Senior Quality Assurance Officer (Sr. Quality Officer) coordinates development and management of Quality Management Systems documents (e.g., SOPs, training, sponsor documents).

This position performs audits (e.g., process, project, vendor, investigator site), as appropriate, hosts customer audits, participates in regulatory inspections, performs quality control review of regulatory documents as needed, and supports quality issue/deviation investigations as directed of Allucent Quality Department.

This position controls and monitors quality activities.

Key Responsibilities:

  • Development and management of quality documentation, to included but not limited to, SOPs, training, sponsor documentation
  • Performs quality control review of regulatory documents as needed
  • Supports quality issues/incidents/deviations
  • Hosts customer audits
  • Participates in regulatory inspections
  • Perform audits (e.g., process, project, vendor, investigator site), as appropriate
  • Actively support staff learning & development within the company
  • Draft and contribute, as Subject Matter Expert (SME) in the field of Sr. Quality Officer, activities in the evaluation/improvement of processes and procedures within the Quality Management System.
  • Assure good communication and relationships with (future) clients
  • Contribute and take part in client evaluations, visits and bid defense
  • Support other quality activities (e.g., vendor audits, internal process audits, investigator site audits) as directed
  • Contribute to other areas of business and other duties as assigned

Requirements:

  • Life science, healthcare and/or business degree
  • Minimum 4 years of relevant work experience
  • Minimum 2 years of experience in drug development and/or clinical research
  • Basic knowledge of ICH-GCP (R2), auditing, GDPR/HIPAA, CFR and other applicable (global/local) regulatory requirements
  • Process oriented
  • Analytical skills
  • Strong written and verbal communication skills including good command of English language
  • Representative, outgoing and client focused
  • Ability to work in a fastpaced challenging environment of a growing company
  • Administrative excellence
  • Excellent organizational skills
  • Auditing & SOP experience.
  • Experience hosting audits highly preferred
  • Experienced translating complicated regulations/rules into clear and usable recommendations
  • Business travel is required for this position as needed; 25% or less
  • Basic knowledge of ICH-GCP (R2), auditing, GDPR/HIPAA, CFR and other applicable (global/local) regulatory requirements
  • Analytical & Process oriented with developing leadership skills
  • Strong written and verbal communication skills including good command of English language
  • Effective at problem solving, strategic thinking and conflict resolution

Benefits

  • Comprehensive benefits package
  • Competitive salaries per location
  • Departmental Study/Training Budget for furthering professional development
  • Flexible Working hours (within reason)
  • Leadership and mentoring opportunities
  • Internal growth opportunities and career progression
  • More task variety
  • Financially rewarding internal employee referral program
  • Access to online softskills and technical training via GoodHabitz and internal platforms

To all recruitment agencies:
_ Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes._

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