VP, Quality Assurance — Strategic Leader in Biopharma

Allucent; Amsterdam; On-site; EUR 180,000 - 240,000; Full time

Benefits offered by this job

Competitive salaries

Comprehensive benefits package

Professional development

Mentoring opportunities

Internal growth opportunities

Employee referral program

Recognition programs

Job summary

Allucent seeks a VP, Quality Assurance to lead the strategic vision, operations, and financial health of the Quality organization. You will plan, prepare, and oversee customer audits/inspections and drive KPIs in line with SOPs and client expectations.

You will participate in Allucent's Leadership team and report on strategy and performance. Responsibilities include developing procedures, leading executive meetings, managing audits, and maintaining client relationships to win new business.

Qualifications

• Life science, healthcare and/or business degree is required.
• 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 and strong analytical skills.

Responsibilities

• Lead to identify, develop and implement the business strategy for the Quality department.
• Develop and agree upon operating procedures / business processes.
• Head over enterprise management team meetings.
• Review audit reports (process, project, vendor) as applicable.
• Maintain and develop organizational culture, values and reputation.
• Report to 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.

Skills

Leadership

Quality assurance

Regulatory knowledge

Auditing

ICH-GCP

GDPR

FDA compliance

Strategic planning

Analytical skills

Decision making

Critical thinking

Team management

Client relations

Education

Life science degree

Healthcare or business degree

Job description

Allucent seeks a VP, Quality Assurance to lead the strategic vision, operations, and financial health of the Quality organization. You will plan, prepare, and oversee customer audits/inspections and drive KPIs in line with SOPs and client expectations.

You will participate in Allucent's Leadership team and report on strategy and performance. Responsibilities include developing procedures, leading executive meetings, managing audits, and maintaining client relationships to win new business.