Randstad Quality Manager- Clinical/Scientific in Waltham, Massachusetts
Quality Manager- Clinical/Scientific
salary:$70 - $75 per hour
date posted:Monday, March 12, 2018
Provide Quality oversight of cGMP supply chain and external manufacturing operation activities.
Provide Quality oversight of cGMP supply chain and external manufacturing operation activities. Support Quality relationship management including oversight of process performance qualification, technology transfers, PAI readiness, investigations, change controls, product disposition and Quality Management Systems, as needed. Role may require some travel both domestic and international.
Duties and Responsibilities:
Provide end-to-end Quality oversight of cGMP supply chain and external manufacturing operations.
Provide support of process performance qualification activities including document review and approval.
Provide Quality support for clinical and commercial technology transfers to contract manufacturing organizations.
Provide PAI readiness support including on-site support of CMOs, as needed.
Provide Quality guidance and support for investigations and change controls.
Batch record review and release of product.
Travel, as needed to contract manufacturing organizations to support products.
BS/University degree required, Life/Health Sciences preferred.
A minimum of 8 years in the Pharmaceutical Industry, and a minimum 4 years Quality (Biologics).
Experience working with external partners (e.g. contract manufacturing organization, contract laboratories and suppliers)
Experience with biologics drug substance and drug product manufacturing preferred.
Understanding of and ability to apply pharmaceutical/biotech cGMP regulations and guidance using a risk-based approach
Exude a passion for relationship building both inside and outside the company.
Demonstrate strong leadership capabilities, but also the ability to actively listen.
Ability to influence in a matrix organization.
Manage through ambiguity, work independently and prioritize the workload with minimal direction.
Demonstrate excellent communication skills both internally and externally.