Associate Director GMP Quality Control

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

Requirements:

* 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

Education:

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