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22 days old

Quality Manager

Kelly Services
Rocky Hill, CT 06067
Kelly Services is seeking a Quality Manager. (Pharmaceutical Manufacturing background)


Job Description:

This is a senior level manager position responsible for the day-to-day management of all quality functions.

This position will serve as a key leader to drive an environment of quality excellence and sustained FDA regulatory compliance.

Individual will provide direct management and decision making for quality laboratory operations and testing, production and process quality measures, investigations, batch release determination and management of FDA inspections and interactions.


Main Responsibilities:

Assist senior management in developing, and leading the implementation and execution of company quality and FDA regulatory strategy related to compliance of FDA regulated OTCs drug products Manage organization s vendor and supplier qualification program supporting and OTC monograph drug production operation OTCs, in collaboration with cross-functional team members and 3rd party resources.

Manage review and approval process for the release of branded and Private Labeled OTCs products.

Manage packaging process for OTCs, medical devices and cosmetic products, including label reviews and tamper evident packaging.

Manage company process for warehousing and storage of OTCs, medical devices and cosmetic products.

Lead training sessions and workshops on best practices for associates and suppliers on FDA compliance.

Ensure that OTC products are properly registered and listed with regulatory authorities US FDA Assist in the import compliance issues resolution and process refinement

Manage the OTC product market withdrawal and recall program

Design, manage and communicate supplier status updates related to OTCs products.


Requirements:

Bachelors degree or higher in Biological Sciences, Chemistry, Pharmacy, Engineering or a related field.

At least 10 years experience in business, consulting, governmental or non-governmental organization focused on retail products.

At least 3 years experience supervising the work of others, including management level direct reports.

Knowledge and understanding of FDA regulations, guidelines and best practices related to OTCs drug products, including CGMPs, OTC drug monographs, labeling, product/lot release, recall management and complaint handling.

Knowledge and understanding of US and Canadian OTC, medical devices and cosmetic regulatory requirements and ability to identify risks and opportunities.

Ability to work collaboratively, engage comfortably with senior executives, work effectively in cross-functional organization.

Organized and self-motivated, strong project management skills in order to multi-task and manage multiple projects simultaneously from beginning to end within a fast-paced environment with changing priorities.



Must have experience in OTC drug/pharmaceutical manufacturing, quality assurance/quality control/drug, GMP, and quality management systems



Our client offers an excellent benefit package including medical, dental, company-paid life, voluntary life, voluntary long term disability, 401k, Paid holidays, vacation and personal time. Bonus eligible Incredible business development opportunity to develop growth and long-term value



Relocation potential for those looking to live/work in the Hartford, CT area





Apply now for immediate consideration.




**Why Kelly** **** **?**



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**About Kelly** ****




At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-08-28 Expires: 2020-10-12

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Quality Manager

Kelly Services
Rocky Hill, CT 06067

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