Senior Specialist- Quality Assurance (Hybrid)

Job DescriptionOur team within our Research & Development Division's Quality Assurance, Global Development Quality organization is responsible for oversight of manufacturing activities for the Clinical Supply Chain. Partnering across our internal facilities and external contract manufacturers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. We are looking for strong leaders with an international and cross-functional mindset, strong interpersonal skills, the ability to maintain and develop strong working relationships with network leaders and progress our systems and process development to the next level.The Sr. Specialist, Clinical Supplies Quality Operations & Technology, plays a critical role supporting the enabling functions within Quality for Medical Device and Combination Product (MDCP) assembly and packaging operations in the Clinical Supply Chain. This includes execution of program strategies, improvement initiatives, ensuring operational readiness / risk mitigation for clinical MDCP operations in support of our company's current and future MDCP pipeline. The position collaborates closely with the key stakeholder groups including Global Clinical Supplies, Global Quality, Global Regulatory Affairs, Global Clinical Trial Operations, Device Development and our Research & Development Division's IT team as well as multiple Quality Assurance sites and functions within the clinical supply chain.Primary Responsibilities:• Maintain in-depth technical / quality expertise on MDCPs and GMP requirements in support of program specific Device / Analytical Working groups and relevant impact on the Clinical Supply Chain.• Represent Device Quality Operations & Technology to bring awareness and alignment to Cross- functional Quality support teams across the stages of manufacture for both internal and external combination product programs.• Independently support / approve documentation required to support Clinical Operational Readiness for MDCPs inclusive of SOPs, Change Management, Deviation investigations, Analytical Method and Specification approval• Participate in Device Specific Risk Management activities for clinical readiness.• Identify need for / and or develop SOPs to ensure effective and robust Quality systems and processes are in place for Clinical MDCPs.Education Minimum Requirements:• Bachelor's degree in engineering, Biology, Chemistry or related field.• 5 years of relevant experience working within the pharmaceutical industry or advanced Degree with 3 years relevant experience.Required Experience:• Understanding and experience in Research & Development activities specifically related to clinical supplies, Medical Device/Combination Products, and implementation of new technology, coupled with the ability to interact with and influence stakeholder subject matter experts on various initiative and issues.• Advanced comprehension of regulatory agency regulations and requirements coupled with proficiency in interpreting and applying current Good Manufacturing Practices (cGMPs) to our Research & Development environment.• Proven track record of developing cross-functional teamwork, collaboration, influencing and negotiation skills.Preferred Experience and Skills:• Demonstrated knowledge of continuous improvement and project management methodologies; ability to lead matrix teams and support complex cross-functional initiatives, recognize improvement opportunities, develop appropriate solutions and follow through on implementation.• Demonstrated excellence of skill in communicating (oral and written) effectively with diverse individuals/ groups at all levels.• Demonstrated experience in quality risk management in the pharmaceutical industry.• Computer skills; knowledge and competency in ERP/MES, PowerPoint, Excel and Word.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERECurrent Contingent Workers apply HEREUS 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 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 RightsEEOC GINA SupplementPay Transparency NondiscriminationWe 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 ActsU.S. Hybrid Work ModelEffective 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, generally Tuesday, Wednesday and either Monday or 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”.Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:$101,100.00 - $159,100.00Available 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.Search Firm Representatives Please Read CarefullyMerck & 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:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:HybridShift:1st - DayValid Driving License:NoHazardous Material(s):n/aJob Posting End Date:08/23/2024• 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.