**Job Description** Director, Microbiological Quality and Sterility Assurance (MQSA) is responsible for providing leadership and direction for microbiology related topics in sterile, non-sterile, biologic manufacturing, vaccine manufacturing and/or microbiology laboratories for assigned topics. **Primary activities include, but are not limited to:** + Leads the development, deployment and maintenance of multiple divisional quality standards and divisional policies to ensure our Manufacturing Division is compliant to cGMPs for these topics. + Leads divisional projects across internal and external sites. + Leads team in development of strategy and assigning project and site support for MQSA. **Education Minimum Requirement and Experience:** + Bachelor of Science (BS) Degree in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Engineering, or related science discipline with ten (10) years’ experience in sterile pharmaceutical industry. **OR** + Master of Science (MS) Degree in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Engineering, or related science discipline with eight (8) years’ experience in sterile pharmaceutical industry. **OR** + PhD in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Engineering, or related science discipline with six (6) years’ experience in sterile pharmaceutical industry **Required Experience and Skills:** + 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. Good teacher. + 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 + Expert knowledge of topics related to sterile, non-sterile, or biologic processing and/or microbiology methods including contamination control. + Experience in transforming GMP compliance and highly experienced in regulatory inspections and responses. + Excellent spoken and written English. Demonstrates strong leadership capabilities and ability to work cross functionally to develop solutions and champion a position. + Demonstrated ability to effectively work hands-on with shop floor personnel. Ability to upskill individuals on topics such as microbiological methods, requirements/regulations, microbiological contamination control. + Expert knowledge of international GMPs and Quality Management requirements of various regulatory agencies such as US FDA, EMEA, TGA, ANVISA, and PMDA. + Knowledge of USP and EU compendia and ISO industry standards. + Quality Risk Management knowledge and experience. **Preferred Skills:** + External involvement in Industry organizations and groups is desirable Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld) Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld) **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf) EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/) **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $169,700.00 - $267,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 25% **Flexible Work Arrangements:** Hybrid **Shift:** 1st - Day **Valid Driving License:** Yes **Hazardous Material(s):** N/A **Required Skills:** Collaboration, Communication, Customer-Focused, Leadership, Microbiological Test, Microbiology, Pharmaceutical Industry, Pharmaceutical Quality Control (QC), Regulatory Compliance, Regulatory Inspections, Regulatory Policies, Sterile Manufacturing, Sterile Operations, Technical Writing **Preferred Skills:** **Job Posting End Date:** 08/18/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R358515