VP, Quality Assurance
Allucent · Munich, Germany
Job description
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
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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 (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 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 ----- ) 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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