Sr. Quality Assurance Officer

<p>Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.</p><p>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.</p><p></p><p><strong>Summary</strong>:</p><p>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.<br/></p><p>This is a full-time, direct hire opportunity for an experienced QA Professional residing in Eastern or Western Europe. Ideal candidates should have a strong GCP/Clinical background and experience managing global quality issues within a CRO/Pharma/Biotech/Lab environment. Some travel as needed for business needs. This position will be hybrid for those living near our Milan office, however, for those further in distance the role can be offered remotely. <strong>PLEASE BE SURE TO SUBMIT RESUMES IN ENGLISH.</strong></p><p></p><p><strong>Key Responsibilities:</strong></p><ul> <li>Development and management of quality documentation, to included but not limited to, SOPs, training, sponsor documentation</li> <li>Performs quality control review of regulatory documents as needed</li> <li>Supports quality issues/incidents/deviations</li> <li>Hosts customer audits</li> <li>Participates in regulatory inspections</li> <li>Perform audits (e.g., process, project, vendor, investigator site), as appropriate</li> <li>Actively support staff learning &amp; development within the company</li> <li>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.</li> <li>Assure good communication and relationships with (future) clients</li> <li>Contribute and take part in client evaluations, visits and bid defense</li> <li>Support other quality activities (e.g., vendor audits, internal process audits, investigator site audits) as directed</li> <li>Contribute to other areas of business and other duties as assigned</li> </ul><p><strong>Requirements</strong></p><ul> <li>Life science, healthcare and/or business degree</li> <li>Minimum 4 years of relevant work experience</li> <li>Minimum 2 years of experience in drug development and/or clinical research</li> <li>Basic knowledge of ICH-GCP (R2), auditing, GDPR/HIPAA, CFR and other applicable (global/local) regulatory requirements</li> <li>Process oriented</li> <li>Analytical skills</li> <li>Strong written and verbal communication skills including good command of English language</li> <li>Representative, outgoing and client focused</li> <li>Ability to work in a fast-paced challenging environment of a growing company</li> <li>Administrative excellence</li> <li>Proficiency with various computer applications such as Word, Excel, and PowerPoint required</li> <li>Excellent organizational skills</li> <li>Auditing &amp; SOP experience.</li> <li>Experience hosting audits highly preferred</li> <li>Experienced translating complicated regulations/rules into clear and usable recommendations</li> <li>Business travel is required for this position as needed; 25% or less</li> <li>Basic knowledge of ICH-GCP (R2), auditing, GDPR/HIPAA, CFR and other applicable (global/local) regulatory requirements</li> <li>Analytical &amp; Process oriented with developing leadership skills</li> <li>Strong written and verbal communication skills including good command of English language</li> <li>Effective at problem solving, strategic thinking and conflict resolution</li> </ul><p><strong>Benefits</strong></p><ul> <li>Comprehensive benefits package</li> <li>Competitive salaries per location</li> <li>Departmental Study/Training Budget for furthering professional development</li> <li>Flex