Director Quality Assurance Opus Scientific New York City

Job description
Global, dominant company seeks a progressive Manager who enjoys a challenge and can lead others in a family oriented company that employs individuals who want to make a significant impact in developing life saving therapies.

Responsibilities
Provide leadership for the company's Quality Assurance activities while overseeing cGMP compliance initiatives and manage resources effectively.

Partner with the Manufacturing department to assure all standards, regulations and guidelines are followed in the manufacture of company products.
Interacts with all areas and levels of the company in addition to regulatory agencies, vendors, consultants and other intended parties.
existing QA systems and implementing new systems and procedures to improve and ensure product quality.


Responsible for review and approval of validation protocols and reports
Approve or reject all containers, components, in process materials and drug products
Review production records and ensure compliance
Hire, train and manage staff
Responsible for fostering a culture and practice of continuous improvement
Represent the quality function with regulatory authorities and customers.


Qualifications

BS in Science
Minimum 8 years of experience in pharmaceutical or biologics Quality Assurance or Manufacturing


Salary commensurate with experience- strong base salary plus 20% bonus

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