VP Quality Assurance & Regulatory Strategy

Allucent; Paris; Sur place; EUR 180 000 - 240 000; Plein temps

Avantages offerts par ce poste

Competitive salaries and comprehensive

benefits package

Departmental study/training for growth

Mentoring opportunities

Internal growth opportunities

Employee referral program

Loyalty Award Program

Résumé du poste

Allucent seeks a VP, Quality Assurance to lead the strategic vision and operations of our Quality organization in Paris. You will oversee audits, regulatory compliance, and the financial health of the function while partnering with the Leadership team to drive client value and success.

You will shape QMS processes, mentor senior leaders, and represent the Quality function in executive reviews as we grow our biopharma footprint.

Qualifications

• 15+ years of relevant work experience in QA leadership.
• 12+ years in drug development and/or clinical research.
• Thorough knowledge of ICH-GCP (R2), GDPR, FDA and international quality management system regulations.
• Process oriented with strong analytical skills.
• Excellent leadership and communication abilities.

Responsabilités

• Develop and agree upon operating procedures / business processes
• Head over executive and senior 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 Quality
• Support regulatory authority inspections as needed
• Represent Quality organization in key meetings (Monthly Business Review, Board)
• Monitor and assure client satisfaction on existing projects for Quality
• Identify key accounts and maintain strong relationships to win new and repeat business

Connaissances

Strategic QA leadership

Auditing & regulatory compliance

Stakeholder management

Quality metrics & KPIs

People leadership

Formation

Life science, healthcare and/or business degree

Description du poste

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 the company Leadership team.

At the company™, 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.

Key Responsibilities

• 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

Benefits

• Competitive salaries and a comprehensive benefits package
• Departmental Study/Training for furthering professional development
• Mentoring opportunities
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Eligibility for our internal employee recognition programs for going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

About The Company

Our mission is to help bring new therapies to light. When you work at the company, that means applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.

If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.

Together we SHINE. find more information about our values.

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.