The Quality Assurance Officer II (Quality Officer II) coordinates development and management of Quality Management Systems documents as needed, performs audits as appropriate, co-hosts and may lead customer audits, supports quality issue/deviation/CAPA closures, participates in regulatory inspections, and performs quality control review of regulatory documents as needed of Allucent Quality Department and other quality activities as directed. This position monitors quality activities.
In this role your key tasks will include:
- Development and management of quality documentation, including but not limited to, SOPs, training, and sponsor documentation as directed
- Co-host and may lead customer audits
- Participate in regulatory inspections
- Perform audits (e.g., process, project, vendor, investigator site), as appropriate
- Perform quality control review of regulatory documents as needed
- May lead quality issue/deviation investigation, follow-up/closure, and CAPA closures as directed
- Provide essential training oversight management, leading maintenance of training curricula and learning management system administration as directed
- Assist with the development and delivery of training materials as agreed with senior management
- Actively support staff learning & development within the company
- Draft and contribute, as Subject Matter Expert (SME) in the field of Quality Officer, activities to the evaluation and harmonization of processes and procedures within the Quality Management System
- Assure good communication and relationships with (future) clients
- May contribute and take part in client evaluations, visits and bid defenses
- May act as primary contact within the quality staff for dedicated areas/assignments
- Support other quality activities (e.g., RFI and vendor questionnaire, quality metrics and CSV) 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 3 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
- 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
- Strong organizational skills
- Time management skills
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)
- Participation in our enriching Buddy Program as a new or existing employee
- Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
- Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
- Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.
“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.”
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Skills Required
- Life science, healthcare and/or business degree
- Minimum 3 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 regulatory requirements
- Process oriented
- Analytical skills
- Written and verbal communication skills including good command of English
- Representative, outgoing and client focused
- Ability to work in a fast-paced challenging environment
- Administrative excellence
- Proficiency with computer applications such as Word, Excel, and PowerPoint
- Strong organizational skills
- Time management skills
What We Do
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients.
