VP, Quality Assurance

United States Digital Space LLC; München; Vor Ort; EUR 180.000 - 260.000; Vollzeit

Benefits dieser Stelle

Competitive salaries

Comprehensive benefits package

Departmental Study/Training

Mentoring opportunities

Internal growth opportunities

Employee referral program

Loyalty Award Program

Zusammenfassung

United States Digital Space LLC in Munich seeks an accomplished VP of Quality Assurance to lead strategic vision, operations, and financial health of the Quality organization. You will oversee planning and execution of customer audits/inspections and drive KPIs in line with SOPs, regulatory guidelines, client contracts, and expectations.

You will join the Leadership Team. You should bring life science/healthcare/business degree and at least 15 years of relevant experience, including 12 years in

Qualifikationen

• Minimum 15 years of relevant work experience.
• Minimum 12 years in drug development and/or clinical research.
• Thorough knowledge of ICH-GCP (R2), auditing, GDPR, FDA and international quality management system regulations.
• Strong leadership and people-management capabilities.
• Excellent presentation and networking skills.
• Ability to work in a fast-paced, growing company.
• Strong business acumen and financial oversight.

Aufgaben

• 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

Kenntnisse

Analytical skills

Leadership

Strategic thinking

Regulatory compliance

Decision making

Project management

Client facing

Financial acumen

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 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:

• 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

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.

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.