VP, Quality Assurance
Allucent
Summary
We have a rare opportunity for a VP, Quality Assurance to join our A-team. In this role you will be responsible for leading the strategic vision, operations, and financial health of the Quality organization. You will be responsible for planning, preparation and execution oversight of customer audits/inspections. You will lead approaches for quality KPIs/metrics and other activities in accordance with the standard operating procedures, regulatory guidelines, executed client contract and the clients’ expectations. You will take part in the Allucent Leadership team.
Job description
Key responsibilities:
- Lead to identify, develop and implement the business strategy for the Quality department.
- Develop and agree upon operating procedures / business processes
- Head over (executive and senior) management team meetings
- Review audit reports (e.g., process, project, vendor), as applicable
- Maintain and develop organizational culture, values and reputation
- Report to applicable internal stakeholders on business strategy, planning, results and performance for the Quality department.
- Support regulatory authority inspections as needed
- Represent Quality organization in key meetings (e.g., Monthly Business Review, Board).
- Monitor and assure client satisfaction on existing projects for the Quality department
- Identify key accounts and maintain strong long-lasting relationships to win new and repeat business
We're looking for someone with:
- Life science, healthcare and/or business degree
- Minimum 15 years of relevant work experience
- Minimum 12 years of experience in drug development and/or clinical research
- Thorough knowledge of ICH-GCP (R2), auditing, GDPR, FDA and international quality management system regulations and expectations (e.g., 21 CFR Part 11) and applicable (local) regulatory requirements
- Process oriented
- Strong analytical skills
- Decision-making capabilities
- Critical thinking skills
- Management skills including, but not limited to, oversight of teams
- Representative, outgoing and client focused
- Ability to work in a fast-paced challenging environment of a growing company
- Strong leadership skills
- Excellent presentation and networking capabilities
- Excellent organizational, negotiating and financial skills
- Strong Business Acumen
Requirements
- Life science, healthcare and/or business degree
- Minimum 15 years of relevant work experience
- Minimum 12 years of experience in drug development and/or clinical research
- Thorough knowledge of ICH-GCP (R2), auditing, GDPR, FDA and international quality management system regulations and expectations (e.g., 21 CFR Part 11) and applicable (local) regulatory requirements
- Process oriented
- Strong analytical skills
- Decision-making capabilities
- Critical thinking skills
- Management skills including, but not limited to, oversight of teams
- Representative, outgoing and client focused
- Ability to work in a fast-paced challenging environment of a growing company
- Strong leadership skills
- Excellent presentation and networking capabilities
- Excellent organizational, negotiating and financial skills
- Strong Business Acumen
Benefits
- Competitive salaries
- Comprehensive benefits package
- Professional development
- Mentoring opportunities
- Internal growth opportunities
- Employee referral program
- Employee recognition programs
- Loyalty Award Program
Company overview
Allucent is a global, full-service contract research organization (CRO) dedicated to partnering with small and mid-size biopharmaceutical companies to advance innovative therapies through every phase of drug development. Founded in 2022 through the merger of several high-performance companies, Allucent combines over 30 years of collective experience in regulatory trends, therapeutic expertise, and operational excellence. The company specializes in oncology, neuroscience, and infectious diseases, with cross-therapeutic capabilities in rare diseases and advanced therapies like cell and gene therapy. With offices across North America, Europe, and the Middle East, Allucent has conducted trials in more than 60 countries, focusing on complex development areas that address unmet medical needs. The company's mission is to 'help bring new therapies to light' by providing comprehensive drug development solutions including clinical operations, regulatory strategy, clinical pharmacology, biometrics, and pharmacovigilance services. Allucent's individualized partnership approach and flexible regulatory solutions help biopharma clients accelerate development timelines, overcome complexity, and deliver life-changing treatments to patients worldwide.