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Associate Director / Director Quality GCP Auditing

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Support

Projektbeschreibung

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS

- Demonstrates the ability to successfully plan, adjust, manage and optimize all resources (budgets, staff, technology, etc.) for advancement of all goals and objectives.
- Demonstrates broad expertise related to understanding the principles and application of quality and regulatory compliance related to GCP regulated activities
- Demonstrates strong aptitude for facilitating group or project team endeavors, and building team unity
- Demonstrates advanced ability to effectively communicate and influence the outcomes of the decision making process
- Displays highly developed organizational leadership qualities
- Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines
- Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to GCP quality systems and management.
- Helps craft department goals and ensures linkage to individual goals
- Displays highly effective coaching abilities as well as a successful track record of developing junior staff
- Conduct presentations on quality issues, initiatives and projects at cross functional meetings
- Approves work related travel and expense reports for members of their functional group
- Ensures appropriate systems are in place for monitoring global procedures and practices
- Ensures that service providers, facilities, personnel, procedures, and practices are critically evaluated to consistently meet regulatory requirements.
- May act as department head.
- Performs other duties as assigned

KEY RESPONSIBILITIES:

- Development, implementation, and oversight of quality activities in support of GCP activities conducted or monitored by Vertex Pharmaceuticals Inc. These activities include qualification and monitoring of GCP Service Providers, monitoring internal GCP quality systems, supporting regulatory inspections, performing duties required of an internal Quality Assurance Unit, and building cross-functional agreements on strategic quality initiatives.
- Collaborates with internal departments on strategy and implementation of quality principles and regulation requirements.
- Provides Quality insight/feedback to internal departments. This may come in the form of SOP reviews and/or ad-hoc requests.
- Development and reporting of compliance metrics related to GCP activities
- Coaches/mentors staff as a means to ensure performance and professional development
- Establishes/maintains effective cross functional team communications to advance quality activities
- This position requires up to 20% travel.

To find out more about Real Staffing please visit www.realstaffing.com

Projektdetails

  • Einsatzort:

    Massachusetts, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Permanent

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland