Location: Atlanta, GA
Company Overview
Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs approximately 5,600 people and operates in more than 150 countries worldwide. Merial is the animal health division of Sanofi.
We are a forward-looking company with a proven track record, producing pharmaceutical products and vaccines for livestock, pets and wildlife. We are on the cutting edge of product development and innovation, providing millions of doses worldwide annually to keep livestock and pets healthy.
We are a forward-looking company with a proven track record, producing pharmaceutical products and vaccines for livestock, pets and wildlife. We are on the cutting edge of product development and innovation, providing millions of doses worldwide annually to keep livestock and pets healthy.
Job Description
Reporting to the Senior Director of Quality Assurance, the incumbent provides leadership and management to a functional group within the North American Quality Assurance organization in support of new product registrations in Merial. Contributes to the design, development, implementation and maintenance of strategies, quality systems and procedures to ensure the integrity of all Merial research output intended for regulatory submission.
Major Responsibilities, include but are not limited to, the following:
Reporting to the Senior Director of Quality Assurance, provide management of personnel who may be at multiple sites in North America.
Establish effective strategies, quality systems and procedures to assure appropriate compliance with all GCP/GLP directives as they relate to the development of pharmaceutical and biological products in North America.
Establishes and allocates Quality Assurance resources from assigned functional group to support all appropriate worldwide Merial R&D objectives. Provides detailed information to the Functional Planner, R&D Leaders, Project Planners and other functional groups regarding the progress of QA work related to R&D projects.
Manages resources from assigned functional group to conduct audits and inspection of internal Merial facilities to ensure compliance with GCP/GLP requirements.
Coordinate the development, implementation and recording of suitable training programs to ensure contemporary awareness of GCP/GLP principles for all research personnel affected by compliance requirements with these practices.
Manages resources from assigned functional group to conduct audits and inspections of external vendors, trial sites, laboratories or other facilities to ensure adherence with Merial quality requirements.
Assist in the coordination of departmental administrative procedures, including: performance planning and review, promotion planning, hiring etc.
Ensure all the activities of assigned functional group are compliant with all R&D and Corporate procedures and any applicable regulatory requirements. Ensure that all Corporate HSE procedures and policies are strictly adhered to.
Facilitate regulatory inspections and report results of such inspections periodically to management.
Advise functional staff regarding regulatory compliance and industry expectations.
Qualifications
Master's degree in a scientific discipline and 6 years experience in the animal GCP/GLP requirements or a Bachelor's degree and 8 years related experience.
In addition to a general quality assurance background, prior experience in performing GCP, GLP and GMP audits in the pharmaceutical industry is essential.
Working knowledge of US and EU GCP/GLP requirements.
Strong oral and written communication skills and interpersonal skills. Ability to work in a project team environment and network across the division.
Fluency with MS Word, PowerPoint and Excel software is recommended.
Merial is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment regardless of their race, color, religion, sex, national origin, or any other characteristics protected by applicable law.
To all recruitment firms: Merial does not accept agency/search firm referrals for this posting, or other postings, without prior written permission from Merial Human Resources. Merial is not responsible for any fees related to unsolicited resumes.
Due to tracking regulations, only resumes submitted directly viahttp://myhr.sanofi.com for internal employees andwww.merial.us/Careers for external applicants will be considered.
Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs approximately 5,600 people and operates in more than 150 countries worldwide. Merial is a Sanofi company. For more information, please seewww.merial.com
M*
Merial Limited is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment regardless of their race, color, religion, sex, national origin, or any other characteristics protected by applicable law.
Major Responsibilities, include but are not limited to, the following:
Reporting to the Senior Director of Quality Assurance, provide management of personnel who may be at multiple sites in North America.
Establish effective strategies, quality systems and procedures to assure appropriate compliance with all GCP/GLP directives as they relate to the development of pharmaceutical and biological products in North America.
Establishes and allocates Quality Assurance resources from assigned functional group to support all appropriate worldwide Merial R&D objectives. Provides detailed information to the Functional Planner, R&D Leaders, Project Planners and other functional groups regarding the progress of QA work related to R&D projects.
Manages resources from assigned functional group to conduct audits and inspection of internal Merial facilities to ensure compliance with GCP/GLP requirements.
Coordinate the development, implementation and recording of suitable training programs to ensure contemporary awareness of GCP/GLP principles for all research personnel affected by compliance requirements with these practices.
Manages resources from assigned functional group to conduct audits and inspections of external vendors, trial sites, laboratories or other facilities to ensure adherence with Merial quality requirements.
Assist in the coordination of departmental administrative procedures, including: performance planning and review, promotion planning, hiring etc.
Ensure all the activities of assigned functional group are compliant with all R&D and Corporate procedures and any applicable regulatory requirements. Ensure that all Corporate HSE procedures and policies are strictly adhered to.
Facilitate regulatory inspections and report results of such inspections periodically to management.
Advise functional staff regarding regulatory compliance and industry expectations.
Qualifications
Master's degree in a scientific discipline and 6 years experience in the animal GCP/GLP requirements or a Bachelor's degree and 8 years related experience.
In addition to a general quality assurance background, prior experience in performing GCP, GLP and GMP audits in the pharmaceutical industry is essential.
Working knowledge of US and EU GCP/GLP requirements.
Strong oral and written communication skills and interpersonal skills. Ability to work in a project team environment and network across the division.
Fluency with MS Word, PowerPoint and Excel software is recommended.
Merial is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment regardless of their race, color, religion, sex, national origin, or any other characteristics protected by applicable law.
To all recruitment firms: Merial does not accept agency/search firm referrals for this posting, or other postings, without prior written permission from Merial Human Resources. Merial is not responsible for any fees related to unsolicited resumes.
Due to tracking regulations, only resumes submitted directly viahttp://myhr.sanofi.com for internal employees andwww.merial.us/Careers for external applicants will be considered.
Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs approximately 5,600 people and operates in more than 150 countries worldwide. Merial is a Sanofi company. For more information, please seewww.merial.com
M*
Merial Limited is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment regardless of their race, color, religion, sex, national origin, or any other characteristics protected by applicable law.
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