5+ years of experience
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Employment Type:
Full time
Job Category:
Health Care Provider
Director of Quality and Regulatory Affairs
Aphena Pharma Solutions | Cookeville, Tennessee
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Job Description

Director of Quality & Regulatory Affairs This opportunity is in Cookeville, Tennessee, home to Tennessee Tech and a little over 100,000 people in the surrounding area. It has small town integrity, low cost of living, strong school system, and an acclaimed regional health care facility. 

Cookeville is surrounded by waterfalls, hiking trails and lakes supporting a healthy outdoor lifestyle. A leading provider of services to the pharmaceutical and healthcare industries seeks strategic thinker who will be responsible for the development, alignment and implementation of the Company’s Quality Management Systems, Regulatory and Complaint Management strategies. Serves as the Designated Representative to government officials of states and other entities. Designs, develops and maintains quality systems. Ensures that cGMP requirements and quality standards are recognized, understood and maintained across the Company. Prepares and leads the audit processes for the internal quality system, customer, DEA, OSHA, AND FDA. Makes recommendations for corrective and preventive actions necessary to ensure conformity with regulatory rules and guidelines. Monitors changes to quality regulations and guidelines, advising the management team of any business implications of these changes. Provide insights, solutions and direction on general business matters. 

Master’s Degree preferred or Bachelor’s Degree required in Technical or Medical field, or a closely related field. Requires 5 to 10 years of experience in Quality Management with this specific job or in a related area. Knowledge of current regulatory requirements and industry standards particularly in the areas of manufacturing and packaging, label control, document management and investigations. Strong knowledge and experience in a highly regulated or FDA environment. Well-organized and detailed oriented professional with strong verbal and written communication. 

We offer a competitive salary and comprehensive benefits package including medical, dental, vision, life insurance, and more. 

EOE/ Equal Opportunity Employer


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About Aphena Pharma Solutions

Aphena provides clients with a full range of solutions to address their pharmaceutical packaging and manufacturing requirements. With our continued investment in technology, advanced packaging systems and rigorous cost control, we can deliver solutions that are highly cost effective as well as comprehensive. Through every step in the development of a product - including concept, manufacturing, packaging and distribution - we provide clients with services and solutions to help ensure a successful product launch. Our team of seasoned experts collaborates with clients and addresses every aspect of their product. We partner with clients to develop the solutions they need to succeed in a highly competitive marketplace, and we're committed to delivering an end result that is on schedule and cost effective.

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