Sr. Quality Assurance Officer

1 miesiąc temu

Warsaw, Polska Allucent Pełny etat

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Sr. Quality Assurance Officer (Sr. QA Officer) to join our A-team (hybrid*/remote). As a Sr. QA Officer at Allucent, you are responsible for the coordination, development and management of Quality Management Systems documents (, SOPs, training, sponsor documents). This position performs audits (, 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.

In this role your key tasks will include:

Development and management of quality documentation, to included but not limited to, SOPs, training, sponsor documentation Hosts customer audits Participates in regulatory inspections Perform audits (, process, project, vendor, investigator site), as appropriate Performs quality control review of regulatory documents as needed Supports quality issue/deviation 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 (, vendor audits, internal process audits, investigator site audits) as directed Contribute to other areas of business and other duties as assigned

Requirements

To be successful you will possess:

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 Reside in the USA (East Coast Region) 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 fast-paced challenging environment of a growing company Administrative excellence Proficiency with various computer applications such as Word, Excel, and PowerPoint required Excellent organizational skills Auditing & SOP experience. Experience hosting audits 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

Benefits of working at Allucent include:

Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our .

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

#LI-Remote #LI-DF1

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