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 ([email protected] ) 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
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Skills Required
- Life science, healthcare, and/or business degree
- At least 15 years of relevant work experience
- At least 12 years of experience in drug development and/or clinical research
- Thorough knowledge of ICH-GCP (R2)
- Knowledge of auditing, GDPR, FDA, international quality management system regulations, 21 CFR Part 11, and applicable local regulatory requirements
- Process-oriented approach
- Strong analytical, critical-thinking, and decision-making skills
- Management experience, including team oversight
- Strong leadership skills
- Client-focused, representative, and outgoing personality
- Ability to work in a fast-paced, challenging environment
- Excellent presentation and networking capabilities
- Excellent organizational, negotiating, and financial skills
- Strong business acumen
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.
