Associate Director Sterile & Microbiology Quality Assurance Job

Associate Director Sterile & Microbiology Quality Assurance Job

18 March, 2016

Associate Director Sterile & Microbiology Quality Assurance-REG002176


Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the and , is a global care leader with a diversified portfolio of prescription medicines, vaccines and animal 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 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, , Microbiology, 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

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

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 : None

Company Trade Name:Merck

Apply now

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