External QA Manager
Posted on Nov 15, 2018 by Affinity Executive Search
* Authority to approve or reject, as seen fit, drug product and finished products.
* Authority to approve or reject written procedures, master batch records, specifications, validation documentation and other vendor documents.
* Authority to review and approve deviations and high level investigation reports.
* Supervision of direct reports.
* Perform quality assessment for change controls both internal and in support of company CMs.
* Support the development and maintenance of Quality Systems.
* Participates as appropriate in management processes for quality and compliance.
* Monitoring of compliance with the requirement of GMP; Evaluation of written procedures, CM production activities and batch records.
* Ensures that the required initial and continuing training of QA Associates is carried out and adapted according to need.
* Lead small teams in the execution of complex, non-routine work assignments. Example: primary QA support for major cross-functional or global projects (new CM on-boarding, product launch, capital project support, etc.)
* Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
* Experience in API manufacturing, packaging, aseptic processing and powder filling operations desired.
* Extensive knowledge of US and European Drug Product GMP requirements and associated guidelines.
* Ability to increase others knowledge of US and European GMP regulations.
* Experience in implementation and administration of quality systems for drug product development, manufacturing and quality control operations.
* Experience in participating in pharmaceutical technology transfer teams.
* Experience in the qualification of facilities, utilities, equipment and processes.
* Has a thorough understanding of the technology, processes, people and equipment of the plant site.
* Has a thorough understanding of the regulatory process from GLP through commercial manufacturing.
EDUCATION AND EXPERIENCE:
* Requires a Bachelors degree in a scientific discipline or equivalent.
* Minimum of 8 yearsexperience in a Quality Assurance role in the pharmaceutical industry.