Asks for

The ad says“Thorough knowledge of ICH-GCP (R3), auditing, GDPR, FDA and international quality management system regulations and expectations (e.g., 21 CFR Part 11) and applicable (local) regulatory requirements”
The ad says“Strong analytical skills”
The ad says“Thorough knowledge of ICH-GCP (R3), auditing, GDPR, FDA and international quality management system regulations and expectations (e.g., 21 CFR Part 11) and applicable (local) regulatory requirements”
The ad says“Strong Business Acumen”
The ad says“Critical thinking skills”
The ad says“Decision-making capabilities”
The ad says“Thorough knowledge of ICH-GCP (R3), auditing, GDPR, FDA and international quality management system regulations and expectations (e.g., 21 CFR Part 11) and applicable (local) regulatory requirements”
The ad says“Excellent organizational, negotiating and financial skills”
The ad says“Thorough knowledge of ICH-GCP (R3), auditing, GDPR, FDA and international quality management system regulations and expectations (e.g., 21 CFR Part 11) and applicable (local) regulatory requirements”
The ad says“Thorough knowledge of ICH-GCP (R3), auditing, GDPR, FDA and international quality management system regulations and expectations (e.g., 21 CFR Part 11) and applicable (local) regulatory requirements”
The ad says“Excellent organizational, negotiating and financial skills”
The ad says“Excellent presentation and networking capabilities”
The ad says“Excellent presentation and networking capabilities”
The ad says“Thorough knowledge of ICH-GCP (R3), auditing, GDPR, FDA and international quality management system regulations and expectations (e.g., 21 CFR Part 11) and applicable (local) regulatory requirements”
The ad says“Management skills including, but not limited to, oversight of teams”

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.

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.

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

Requirements

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 (R3), 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 Allucent

Our mission is to help bring new therapies to light. When you work at Allucent, 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.

Apply now!

If you’re ready to bring your passion for clinical development and business growth to Allucent, apply today or reach out to Ariane des Tombe (ariane.destombe@allucent.com ) for more information.

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

#LI-AdT