Good evening, I'm passing this opportunity along for a friend who doesn't have access to the ListServ.  If you are interested, please contact him directly.  His name is William Gadison, and he's at 
Good evening, I'm passing this opportunity along for a friend who doesn't have access to the ListServ.  If you are interested, please contact him directly.  His name is William Gadison, and he's at [log in to unmask]
 
Thanks.
Earl
 
Earl Johnson, Jr. 
E-mail: [log in to unmask]

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Senior Manager, Compliance and Training
REPORTS TO: Senior Director, Quality and Compliance

POSITION SUMMARY
Responsible for implementing compliance policies and procedures at Site, ensuring alignment with the Corporate Compliance policies.  Tracks result of audits, including corrective actions and provides follow-up to these actions as required.  Coordinates and leads compliance audits of quality systems, manufacturing areas, vendors, QC and other support functions as required.  Performs follow-up audits to regulatory commitments to assure compliance with and efficacy of commitments.  Assesses the state of CGMP compliance through conducting periodic internal audits, using FDA's Systems Inspection approach as a model.  Responsible for conducting GMP Training to new and regular
employees in an on-going basis.

ESSENTIAL AREAS OF RESPONSIBILITY
All areas of responsibility listed below are essential to the satisfactoryperformance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

·    Establishes and maintains an internal auditing program at site, ensuring an alignment with Corporate Compliance policies.
·    Participates and leads cross-site internal audits in accordance with the Corporate Audit Standard.
·    Tracks result of internal and external audits, including corrective actions and provides follow-up as required.
·    Establishes and monitors on-going GMP Training program for new and regular employees.
·    Oversees the administration of the Learning Management Systems (LMS).
·    Oversees the development of curricula for GxP employees, and maintains a system for notification and documentation of training on new and revised procedures.
·    Develops, implements and monitors Quality Technical Agreements with the Site's major Suppliers of APIs, Excepients and Packaging Components.
·    Assists other Senior Managers in the department in conducting ICAR investigations and performing root cause analyses to identify corrective/preventive actions.
·    Assumes leadership role for specific, defined responsibilities as deemed necessary by the department head.
·    Assists Senior Director of Quality Assurance with all regulatory inspection activities.
·    Oversees known inspection preparation activities; e.g. PAI preparation.
·    Hosts partner GMP inspections.
·    Carries out supervisory responsibilities in accordance with company's policies and applicable laws.  These responsibilities include interviewing, hiring, and training of employees; planning, assigning, and directing work; appraising performance, addressing complaints and resolving problems.

MINIMUM QUALIFICATIONS

To perform this job successfully, this individual must be able to perform each primary responsibility satisfactorily.  The requirements listed are representative of knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform
the essential functions.

The individual must have a minimum of a Bachelor's Degree in Science, Engineering, or other applicable discipline with at least 5 ? 8 years of Pharmaceutical or related Industry experience in Compliance or Quality Assurance function, including 3 + years in a managerial capacity.

Strong written and verbal communication skills, organizational and leadership
skills are essential.

Expert knowledge of FDA/European GMP regulations and Compliance is required.

OR

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.



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