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Manager, NA Quality at Mylan Inc

Posted in Other 30+ days ago.

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Type: Full Time
Location: Morgantown, West Virginia





Job Description:

For Us, It\'s A Mission

At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world's 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what's right, not what's easy. If you are a doer and have a passion for serving others, we want to talk to you.

Make a Difference

At Mylan, each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here's how this role will help:

* Collaborate with 3P CMOs and work towards prompt resolution of issues via frequent telephonic/email communication and periodic on-site visitations.

* Design and implement systems to support emerging areas of the business such as consumer health products.

* Participate in applicable operational discussions for 3P CMO manufactured products and support any process optimization initiatives and/or new business opportunities.

* Partner with 3P manufacturer, commercial operations and external distributors to resolve any technical and/or quality issues promptly to ensure continued product supply and minimize disruptions.

* Oversee the NA Quality change control system for affiliate and third party manufacturers to ensure that all proposed changes have been appropriately assessed to ensure compliance with Health Authority requirements as well as with Mylan expectations.

* Support ancillary projects as required, such as product transfers and manufacturing site decommissioning.

* Implement a process for label review and approval for all North America CMO manufactured products.

* Work closely with Mylan regulatory affairs to ensure that all changes to regulatory applications are assessed appropriately and that all required supporting documentation is available. Ensure that implementation of all proposed changes occurs as per the timelines established by the regulatory filing determination.

* Review APR/PQRs and stability data.

* Ensure compliance to current compendia for 3P CMO manufactured products as applicable.

* Liaise with business development groups to assure Quality presence in formation and management of business relationships.

* Develop and maintain training curricula for department personnel as required. Conduct group training as necessary.

* Compile and review data for reporting group metrics and third party scorecards.

Make Our Values Your Values

Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:

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Minimum of a Bachelor's degree (or equivalent) in a scientific field and 2-4 years of experience. A minimum of three years of pharmaceutical experience strongly preferred. However, a combination of experience and/or education will be taken into consideration.
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Must possess knowledge of cGMP, FDA, SUPAC, ICH and outside regulatory agency requirements and the use of Trackwise. Must have knowledge of and be proficient in Excel, PowerPoint and Word.
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Must possess effective written and oral communication and interpersonal skills.
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Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization.
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Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization.
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Ability to perform computations such as percentages, ratios, and rates.
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Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
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May be required to stand, walk, stoop, bend, kneel, and climb steps. May require use of hands and use of arms. Light lifting requirements.
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Normal office situation.
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Proficiency in speaking, comprehending, reading and writing English is preferred.

Why Mylan?

If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 35,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.

Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.
Schedule:
Job Posting: Jun 13, 2018, 8:54:25 AM
Unposting Date: Ongoing.