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.
The Quality Environmental Monitoring (EM) Lead will provide management of the End to End (E2E) Live Virus Vaccine (LVV) EM team, the EM program for Operations of LVV products, regulatory inspection support, and initiation of sterility assurance initiatives at the site. The individual in this role is a member of the E2E Quality leadership team, the EM Center of Excellence (CoE), and additional site leadership teams. This role will be responsible to drive LVV E2E compliance to critical EM business processes/systems and critical programs designed to heighten our contamination control through the use of Lean Manufacturing/Six Sigma, inclusion behaviors, and Change Execution Management.
Qualifications: Education Minimum Requirement:
- Manage a team of 5-10 EM specialists executing tactical and strategic EM objectives for LVV E2E Operations. Develop a high performing team through real time coaching; ensure each team member has a meaningful and up to date personal development plan.
- Work cross-functionally with Operations, Technology, and Quality to identify and remediate EM issues within the LVV E2E and West Point site identified during self-audits, regulatory inspections, process deviations, Quality Manual Gap assessments, or as part of continuous improvement.
- Act with a high degree of autonomy as the LVV E2E subject matter empowered to make decisions and recommendations on behalf of the LVV E2E on matters relating to Merck's EM procedures and policies.
- Manage emerging EM issues for the LVV E2E or West Point site, present to regulatory authorities and Senior Site Leadership, and represent Merck in external associations.
Required Experience and Skills:
- Bachelor's degree in microbiology, molecular biology, biochemistry, biology, or biological engineering
Preferred Experience and Skills:
- 1-2 years people management
- Demonstrated strong problem identification and solving skills
- Aseptic processing/sterility assurance experience
- 5 years experience in Pharmaceutical industry, aseptic/sterile processing highly preferred
- Experience with Lean Manufacturing/Six Sigma, talent development, domestic/international regulatory agencies, project management, and change execution management
- Sterile operations experience in manufacturing sterile biologic or pharmaceutical product
- High technical aptitude and experience in the design, development, implementation and sustainment of an Environmental Monitoring and Cleanroom Conduct program
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 firstname.lastname@example.org. 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.
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