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Supervisor, Quality Assurance

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Support

Projektbeschreibung

Real Staffing Group is urgently seeking a Supervisor, Quality Assurance (Early Phase Pharmaceutical Development) for a well respected pharmaceutical company in theMountain Viewarea.

The Role: Supervises and provides quality support for early drug product development phases and GLP programs. Responsible for in- house and contracted quality functions to support early phase drug product and GLP manufacturing. Quality Systems Project Lead for early development phase and GLP projects. Primary quality signatory for GxP documents in support of the GLP and early phase drug product development activities. Performs all activities and job functions in accordance with the Company's policies and procedures for quality, regulatory, compliance and safety.

Essential Duties and Responsibilities:
* Provides quality guidance to drug product development during early phase and GLP studies.
* Leads continuous improvement activities in the quality arena to support early phase drug product development.
* Supervises project workplans and implements plans.
* Partners with R&D to develop procedures that ensure appropriate quality and compliance.
* Partners with R&D, CMOs and CTOs to ensure on-time deliverables that meet quality requirements.
* Represents the quality function at decision making meetings.
* Supervises production readiness and product release activities to ensure timely delivery of drug product.
* Reports quarterly quality key performance indicator metrics.
* Suggests, implements, and leads appropriate QA approaches to effective corrective actions based on sound principles, industry/regulatory standards and scientific justification.
* Collaborates with the compliance quality group to maintain on-time completion of discrepancies.
* Performs quality review of documents against relevant source documents.
* Authors standard operating procedures (SOPs) and change controls.
* Provides effective customer service.
* Participates as SME in regulatory agency inspections.
* Maintains the master batch records and production batch record files for early phase and GLP operations.
* Maintains a safe and healthy work environment

Education:
* BS/BA degree in related discipline and four years of related experience; or,
* MS/MA degree in related discipline and two years of related experience.
* Typically requires eight years of related experience and/or combination of experience and education/training.
* May require certification in assigned area.

Experience:
* At least 1 year of line management or project supervisory experience
* Proficient at MS office suite, including Visio and Project, and enterprise database systems
* Ability to work effectively in a matrix organization with cross-functional teams
* Ability to manage by influence
* Participation with inspectors during regulatory inspections
* Ability to work with manager to continually ensure projects are appropriately prioritized.
* Knowledge of the regulatory and quality requirements for the manufacture of Pharmaceutical Products as required for FDA or international regulatory agency approval.
* Experience with early phase drug development and GLP regulatory requirements.

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

Projektdetails

  • Einsatzort:

    Mountain View, California, 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