Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.

Associate Director GMP Quality Control

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Support


Essential duties and responsibilities include but are not limited to the following:

* Establish, and maintain the GMP Quality Control (QC) program
* Oversight of MDVN GMP Quality Control activities at contract manufacturing sites and contract analytical test laboratories
* Develop and deploy the quality systems (e.g. laboratory investigations, out-of-specification investigations, LIMS, assay method validation, management review, and process control) to ensure products conform to defined requirements.
* Assist with defining the quality requirements/activities for the analytical laboratory build out as needed
* Working knowledge of Pharmaceutical (CDER) drug, manufacturing, sampling (sample flow) analytical specifications, lab/testing and C of A generation to support phase appropriate material (API, RM, In-process finished and final) release
* Assist with deviation/investigation resolution as needed
* Work with test facilities to resolve analytical issues associated with release and stability testing, including OOS/OOT investigations
* Provide Analytical chemistry and stability management support for clinical trial material
* Review Analytical data originated from release and stability testing and identify trends using established quality systems and risk management tools
* Provide support for CMC preparation and review of regulatory submission, such as IND, IMPD, NDA, MAA
* Regular interact/collaborate with CMO QC management and company Pharmaceutical Operations group


* 10 years of relevant GMP QC experience and 5 years in a supervisory role, particularly in a GMP environment
* Experience with small molecules (oral, dermal )
* Extensive working knowledge of GXP regulations and experience with regulatory compliance inspections
* Extensive experience on quality control and quality assurance principles to a wide range of development documents and records; regulatory submissions

Desired Background and Experience:

* 7-10 years in pharmaceutical industry in a technical capacity with at least 5 years of accomplishments in QC or analytical development
* Excellent knowledge of cGMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical laboratory testing for release, stability and validation
* Demonstrated knowledge of Analytical Chemistry, Microbiology, method validation and transfers
* Experience on boarding an analytical lab
* Experience working with Contract manufacturers and contract test labs


* B.S. degree in Chemistry/Biochemistry or any life science area
To find out more about Real please visit www.realstaffing.com


  • Einsatzort:

    San Francisco, California, Vereinigte Staaten

  • Projektbeginn:


  • Projektdauer:

    Keine Angabe

  • Vertragsart:


  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:


  • Skills:


Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland