Senior Specialist Quality Assurance

Job Description Quality Assurance protects patient rights and well-being, supports compliance with global regulatory requirements through effective processes and procedures, and provides independent assurance of high-quality data and clinical supplies. Key Responsibilities Operational support of Quality oversight of Third-Party Vendors within the API platform and the within TPQM team include: Generate, negotiate, review, assess, and approve Quality Agreements between our Company's Research Labs and its contractors and cross sites and division within our Company supporting clinical supply production. Generate, negotiate, review, and approve assessments for audit refusal and other related quality events at suppliers of GMP materials and services. Serve as quality representative in meetings with internal and external stakeholders, including Quality Disposition and Pharmaceutical Research/Development. Communicate clearly and effectively with internal and external stakeholders. Collect and track Quality Agreement metrics and other operational metrics. Act as TPQM gatekeeper and review GLOSS SOP changes, updates, and new SOPs for TPQM impact or awareness. Collaborate with internal teams and external contractor personnel on tailgate sampling, reduced testing assessments, risk assessments, supply chain mapping, and annual report authorship. In addition to the job specific responsibilities discussed above, the Senior Specialist is expected to independently execute key activities as listed below. Maintain the Quality Agreement Master List and related trackers with accuracy. Support internal audits and inspections as needed. Use, support, and continuously improve TPIC (Third Party Information Center) to enable TPQM workflows and operations. Collect and track Third Party oversight related metrics. Identify and implement process improvements, including opportunities to leverage AI tools. Communicate with senior our Company's leadership and contractor management. Prepare and present cross-functional management updates. Make independent decisions and act with appropriate authority. Identify trends and potential compliance gaps and lead issue resolution to improve quality and efficiency. Interpret regulatory requirements and communicate them effectively across stakeholders. Education Requirements Bachelor's degree in engineering, Biology, Chemistry or related field. Required Experience and Skills A minimum of seven (5) years of relevant experience within the pharmaceutical industry. OR Advanced Degree with a minimum of five (5) years relevant experience. Preferred Experience and Skills Ability to independently engage with external parties. Strong cross-functional teamwork, collaboration, influence, and negotiation skills. Strong knowledge of EU, US, and ROW regulations and application of GMPs in an R&D environment. Knowledge of drug development process. Knowledge of continuous improvement methods; able to identify opportunities and implement solutions. Experience with AI tools applications to streamline workflows and replace manual work with automation when applicable. Strong organizational and time management skills; able to deliver well-defined projects within area of expertise. Ability to manage conflicting priorities proactively. Proficient with Microsoft 365 Office applications (e.g. Power Point, Word, Excel). Required Skills Adaptability Adaptability Audits Compliance Continuous Process Improvement Data Analysis Detail-Oriented Deviation Management Drug Development Due Diligence Employee Training Programs GMP Auditing GMP Compliance Internal Auditing Interpersonal Relationships Manufacturing Processes Manufacturing Quality Control Microsoft Word Negotiation Pharmaceutical Management Pharmaceutical Research Process Improvements Quality Assurance (QA) Quality Assurance Systems Quality Risk Management Regulatory Requirements {+ 1 more} Location Requirements US and Puerto Rico Residents Only 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 Equal Employment Opportunity Statement 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, EEOC GINA Supplement – Learn more about your rights, including under California, Colorado and other U.S. State Acts. Compensation and Benefits The salary range for this role is $106,200.00 - $167,200.00. 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 Job Details Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): No Job Posting End Date: 06/5/2026 Requisition ID: R397240 #J-18808-Ljbffr Merck & Co.