VP, Quality Assurance

Allucent; München; Hybrid; EUR 180.000 - 250.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Professional development

Mentoring opportunities

Career progression

Employee referral program

Loyalty program

Zusammenfassung

Allucent is seeking a VP of Quality Assurance to drive strategy, operations and the financial health of the Quality organization. You will oversee customer audits/inspections, define KPIs, and guide procedures in line with SOPs, regulatory guidelines, and client expectations.

You will be part of the Allucent Leadership team. With a focus on life sciences and clinical trials, this role requires seasoned leadership, deep regulatory knowledge, and a client-focused approach to ensure quality across

Qualifikationen

• 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.
• Strong analytical and decision-making capabilities.
• Excellent presentation and networking skills.

Aufgaben

• Lead the development and implementation of the Quality department strategy.
• Develop and agree upon operating procedures / business processes.
• Chair executive and senior management meetings.
• Review audit reports (process, project, vendor) as applicable.
• Maintain and develop organizational culture, values and reputation.
• Report to stakeholders on business strategy, planning, results and performance for the Quality department.
• Support regulatory authority inspections as needed.
• Represent Quality in key meetings (Monthly Business Review, Board).
• Monitor client satisfaction and maintain strong relationships to win new and repeat business.

Kenntnisse

Leadership

Strategic thinking

Regulatory knowledge

Stakeholder management

Ausbildung

Life science/Healthcare/Business degree

Jobbeschreibung

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

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

• 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.

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