Associate Director of Quality Operations

1 month ago


Boulder, United States Germer International - Pharmaceutical Recruiting Full time

Our client, a global pharmaceutical company, is looking for an Assocaite Director of Quality Assurance who will be responsible for the site Quality Assurance Operational Unit, including main Customer Program QA Point of Contact, Deviation and CAPA Management, Batch Record Release & Review, and Shop Floor QA Oversight.

RESPONSIBILITIES

  • Quality Risk Management

Responsible for end-to-end Operational Quality Risk Management, where the role ensures unacceptable risk levels are escalated, and therefore not compartmentalized in a product program or area of their responsibility.

  • GMP Surveillance and Education

Notify site, executive management; and customers of significant quality, or regulatory investigations, or issues through appropriate reports, or process

  • Organization and Resources

Establish operational Quality objectives and goals for the site based on baselines, operational intelligence, and regulatory requirements. Manage and administer the people processes for personnel in their organization related to the employee lifecycle. This includes the selection and training of personnel on company and local policies and processes. Ensure staff receives appropriate knowledge and skill development

EDUCATION and/or EXPERIENCE

  • Bachelor's Degree from college or university; and 10 years of related experience; or equivalent combination of education and experience.



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