QA Service Director
2 settimane fa
**Job Information**:
Industry
**Technology**
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Work Experience
**5+ years**
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City
**Milano**
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Province
**Lombardia**
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Country
**Italy**
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Postal Code
**20121**
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**About us**:
We are Business and Technology experts in the Life Sciences industry.
We are a long-standing Partner and Service Provider across Clinical Development, Regulatory and Compliance, Quality Management, Pharmacovigilance, and Medical Affairs domains.
We help pharmaceutical, biotechnology, nutraceutical, medical device, universities, hospitals and non-profit organisations to gain the best business value through technology-enabled solutions and achieve excellence in business operations.
- PURPOSE:
Manages and coordinates QA and CSV projects and services in order to meet client’s expectations and business goals, ensuring optimization and respecting Company profitability, with the support of the Services Managing Director.
Ensures appropriate staffing of production activities and development of human resources in line with business objectives. He/She guarantees the alignment of the department with business strategy and goals and ensures operational quality in line with regulatory requirements.
Liaises with the QAS Business Partner to guarantee customer satisfaction via account management support, and develop new business opportunities for the Company.
**Requirements**:
- ACCOUNTABILITIES:
- Identifies successful drivers and defines and manages KPIs for strategic processes to guarantee continuous improvement of QAS services
- Ensures that Department processes are efficient and cost-effective and ready for internal or external Inspections according to a defined strategy
- Ensures department profitability at gross margin level through efficient target allocation rates and resources billability
- Escalates to the Managing Director and the Consulting Business Major/Critical Risks for Client relationships
- Contributes to and ensures optimal public relations activities and brand awareness
- Assesses customers feedback and makes necessary improvements
- Represents the company at client/partner meetings and participates in scientific meetings
- Supervises company Processes
- Consults and supports Project Managers for resolution of priority issues
- Validates the relevant technical aspects of project proposals
- Develops his/her reports
- Performs billable role within Client projects, according to his/her specific background and area of experience within the regulated environment
- Acts as Auditor and QA representative among Clients if required
- Creates regulated documents or specific consultancy services as appropriate
- Monitors resources performances on key processes
- Guarantees compliance with current regulations
- Prepares and gets approval for the yearly plan for the department
- Supports HR in staffing, enhancing employer brand, staff retention and satisfaction
- Ensures that clients receive the requested services ensuring the quality of the project’s deliveries within the agreed budget and profitability
- Manages the QAS project portfolio and its risk
- Ensures accurate revenue recognition on a monthly basis and approved departmental costs
- Manages and approves supplier selection
- BACKGROUND & EXPERIENCE- Bachelors Degree in Life Sciences/Scientific matters
- At least 10 years of relevant work experience in Quality Assurance with at least 5 years of supervisory experience
- English, Fluent
- Essential regulatory guidelines worldwide
- Regulatory norms applicable
- Revenue and cost recognition
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