18 March, 2016
Associate Director Sterile & Microbiology Quality Assurance-REG002176
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Associate Director, Sterile Quality Assurance, is responsible for providing leadership and direction for microbiology related topics in sterile, non-sterile, biologic Manufacturing, and/or Microbiology Laboratories in assigned region(s).
– Leads the development, deployment and maintenance of five or more divisional Quality policies, guidelines, and quality standards to ensure MMD is compliant to cGMPs for these topics.
– Serves as the Microbiology Quality Assurance point of contact for four or more sites in the MMD network.
Education Minimum Requirement:
– Bachelor degree in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Minimum 10 years experience in sterile pharmaceutical industry.
– Experience with EU and/or FDA regulations.
– Broad experienced in microbiology topics related to sterile, non-sterile, or biologic processing and/or microbiology methods.
– Experience in transforming GMP compliance.
– Excellent spoken and written English.
– Demonstrated ability to effectively work hands-on with shop floor personnel.
– Ability to travel up to 50% of the time.
– Advanced degree desirable.
– Expert knowledge of three or more microbiology topics related to sterile, non-sterile, or biologic processing and/or microbiology methods.
– Expert knowledge of international GMPs and Quality Management requirements of various regulatory agencies that may include US FDA, EMEA, TGA, HPB, ANVISA, COFEPRIS, ANMAT, KFDA and PMDA.
– Knowledge of USP and EU compendia and ISO industry standards.
– Quality Risk Management.
– Change Execution Management.
– Project Management.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com.
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Visa sponsorship is not available for this position.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Regulatory Compliance
Job Title:Associate Director Sterile & Microbiology Quality Assurance
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Kenilworth, NA-US-VA-Elkton, NA-US-NC-Durham
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: None
Company Trade Name:Merck
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