**Job Description** **Job Description:** The Rahway based **Senior Specialist, Global Development Quality Operations - API** , is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API manufacture, testing, release, and maintenance in support of our company's clinical supply programs. This person will also independently review and approve documentation accompanying the disposition of API materials (including new modalities such as ADCs) to ensure conformance to appropriate regulatory and company requirements for clinical supply manufacture and/or regulatory inspections. Independently performs audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations and our Company procedures. The Senior Specialist will become knowledgeable in regulatory requirements, cGMPs and our company's procedures to assure API (including new modalities such as ADCs) manufacturing and testing is in compliance and will gain competency in their responsibilities. **Primary responsibilities include but are not limited to the following:** + Perform quality assurance activities related to API (including new modalities such as ADCs) manufacturing in a complex, clinical supply development. Review and/or approve GMP documents. + Ensure all API (including new modalities such as ADCs) are manufactured in compliance with cGMP and regulatory filings. + Perform independent quality review and approval of batch records, testing data, and related documents required to release or reject product. Make independent batch release or reject decisions. + Conduct independent auditing, review, and approval of diverse and complex document types, as required, including deviations, investigations, change records, analytical method validations, method transfers, analytical methods, specifications, certificates of analysis, etc. + Accountable for all assigned projects and communication of status to the Management Team. + Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels. + Establish, educate, and enforce standard operating procedures (SOPs) required under GMP. + Develop/update SOPs to ensure practices are accurately reflected. Assist in SOP and quality-related system document approval. + Support metrics by summarizing findings during documentation reviews. + Collect, prepare and analyze data to support quality system metrics and planning. + Support compliance activities such as site readiness, audits, inspections, and CAPAs. + Support quality risk management activities as facilitator, project lead and/or quality subject matter expert. + Proactively identify, execute and manage independent projects for continuous quality improvement and efficiency. + Support the implementation of the clinical supply QMS through participation as topic team member and/or subject matter expert. + Represent Development Quality on inter-departmental and cross-functional teams, ensuring communication of information and providing quality guidance and/or deliverables. + Exercise broad judgment in making quality decisions and solving complex problems. Escalate issues as needed. + Provide meeting coordination, facilitation, scribing, and communication. + Other duties as assigned by manager for the flexible functioning of the work group. **Education Minimum Requirements:** + Bachelor's degree (B.S.) in an appropriate Science or Engineering discipline (engineering, chemistry, biology, biochemistry, microbiology). Minimum of 5 years' experience with a B.S. **Required Experience and Skills:** + Experience in the pharmaceutical, biotechnology, chemical, medical device, or closely related industry. + Experience in one or more functional areas such as quality assurance, laboratory, manufacturing, production, equipment/facilities management, regulatory. + Good Manufacturing Practice (GMP) or related small molecule API regulation knowledge and expertise. + Strong leadership, collaboration, teamwork, negotiation, communication, problem-solving and workload management skills. + Excellent verbal and written communication including presentation skills. + Demonstrated ability to manage projects, priorities, to meet deliverables and timelines. + Attention to detail, flexibility, and an awareness of production and associated quality problems. + Ability to work in a dynamic environment with rapidly changing needs. + Ability to work across functional and sites, with all levels of staff and management. + Qualified candidates should have proficiency with Microsoft Suite (Word, Excel, PowerPoint, Teams, etc.) and ability to adapt to learning other electronic systems to support day-to-day work. **Preferred Experience and Skills:** + Knowledge of R&D or clinical supply areas and processes. + Small molecule API knowledge and experience. + Large molecule drug substance regulation knowledge. + Large molecule Antibody Drug Conjugate (ADC) manufacturing experience. + System knowledge of Veeva, SAP, Trackwise. + Experience with manufacturing and analytical investigations and CAPAs. 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. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. 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​ Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf) We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected US salary range: $104,200.00 - $163,900.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) . **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:** Yes **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** 1st - Day **Valid Driving License:** Yes **Hazardous Material(s):** No **Job Posting End Date:** 02/19/2025 ***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:** R335019