External QA Manager

Posted on Nov 15, 2018 by Affinity Executive Search

Ohio City, OH 45874
Senior Appointments
Immediate Start
Annual Salary
Full-Time
This function is responsible for managing workflow within and outside of External Commercial QA. This function resolves and supports the daily manufacturing and facility operations of the External Operations Team (Supply Chain, EH&S, Technical Operations, etc.) and company Contract Manufacturers (CM). This function develops and implements tactical initiatives directed by Senior Management. This function communicates events to Management and thresholds events when they are outside of the area of responsibility.

KEY DUTIES:

* 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.)

SKILLS/ ABILITIES:

* 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.

Reference: 559198756

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