Sr. Manager Validation
New Jersey
Are you looking to elevate you career to the next level in Validation? A global top 5 biopharmaceutical company is looking for a talented Sr. Manager Validation to join its rapidly expanding team. This company has received a tremendous amount of recognition for its innovative medicines and therapies. This role will be apart of the division focused on delivering affordable medication to people around the global. If interested in learning more about this incredible role don't to apply!
The Sr. Manager Validation will be responsible for:
Administer and manage Engineering, Qualification and Validation efforts within manufacturing, the Quality Control (QC) laboratory, and facility support systems. Develop and enhance validation programs in accordance with current data integrity and cGMP best practice expectations. Oversee management of qualification protocol development. Oversee applicable computerized system administration. Ensure compliance with FDA, USP, EU, federal and state agencies, and applicable global health authorities.
Administer and maintain risk based, quality driven procedures and practices with respect to engineering, qualification and validation.
Oversee the development and execution of qualification protocols for facility systems, manufacturing equipment, and laboratory instruments.
Provide technical support for system owners and administrators for various facility systems, manufacturing equipment, and laboratory instruments.
Support the change control program
Support the investigations program
Act as a subject matter export during internal, Global Quality, third party, and health authority audits.
Ensure timely, efficient and effective communication and/or interaction with regulatory agencies, internal GxP partners, external contract providers or external contracting organizations.
Perform technical review of qualification related documentation. Provide training/guidance to Quality, Maintenance/Engineering, Manufacturing, and Laboratory personnel on relevant policies and SOPs.
Ideal Candidates will have:
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