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Merck & Company, Inc.

Merck & Co., Inc. provides various health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products. The company provides human health pharmaceutical products, such as therapeutic and preventive agents for the treatment of human disorders in the areas of cardiovascular, diabetes and obesity, respiratory, immunology infectious diseases, neurosciences and ophthalmology, oncology, vaccines, and women's health and endocrine. It also ... Read More

Address      One Merck Drive PO Box 100 Whitehouse Station, NJ 08889-0100 United States
Website      www.merck.com/
Holding      No Holding Details

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Quality Assurance

Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as 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 people 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.
Lead/Principle/ Associate Director,  Sterile Quality Assurance,  is responsible for providing leadership and direction to sterile product manufacturing sites in assigned region(s) for implementation of QA initiatives and Quality policies/guidelines, and achievement of GMP compliance. Under the direction of the Director, Sterile QA, serves as sterile pharmaceutical and vaccine manufacturing expert in development and maintenance of sterile manufacturing standards, policies, guidelines and procedures. Responsible for the following:

    * Work with the sites, regional forums (including the Sterile Council) and other Compliance Directors to ensure sterile network consistency and alignment with the MMD quality manual and cGMP.
    * In partnership with cross functional teams, lead the development and enhancement of key quality assurance programs supporting the MMD sterile manufacturing network.
    * Provide expert support to sites related regulatory inspections, development of responses to inspection observations, significant investigations, and guidance regarding corrective actions.
    * Ensure that compliance issues identified by the sites or through agency inspections are assessed for sterile network impact and effectively resolved.
    * Lead or support Sterile QA and Sterile Council projects, support individual site projects and provide specialist expertise to  regional above-site organizations.
    * Organize and facilitate compliance related communities of practice or focus group meetings as a forum for discussion and common understanding of quality  policy and initiatives, discussion of compliance issues and sharing of best practice.
    * Co-ordinate regional input into draft  policies, procedures and guidelines. Author and/or review technical reports/position papers and present to Quality Council, QSS or other groups. Participation in industry organizations or committees such as ISPE, PDA, PhRMA.

Please note that this position can be located in US or Europe at the Merck local sites.  There is no international relocation offered.
Local candidates are considered.
The sites are as follows:
Local sites in US or Europe:Belgium, France, Netherlands, Ireland, Spain
Education Minimum Requirement:

    * Bachelor degree in Biology, Medical Technology, Microbiology, Chemistry, Pharmacy, Chemical Engineering or related science discipline

Required Experience and Skills:

    * Minimum 10 years experience in sterile pharmaceutical industry; Experience with EU and/or FDA regulations and GMP compliance;

 Preferred  Experience and Skills:

    * Advanced degree desirable
    * 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.

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.  Merck'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.
To be considered for this position, please visit our career site at www.merck.com/careers to create a profile and submit your resume for requisition # REG000976. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.
Search Firm Representatives
Please Read Carefully:
Merck 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.

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Full Time

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