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Job Description

Our 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 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 a science, engineering, or related discipline; an advanced degree or certification in a management, technical, quality, or regulatory discipline will be preferred.

Required Experience Knowledge and Skills:

• A minimum of 5 years of relevant experience working within the pharmaceutical industry or advanced Degree with 3 years relevant experience

• Strong comprehension of regulatory agency regulations and requirements coupled with proficiency in interpreting and applying current Good Manufacturing Practices (cGMPs) to our Research & Development environment.

• Direct experience in GMP quality, operations, or laboratories. GMP experience at the interface between quality and either an internal manufacturing or laboratory function or external contract manufacturing, laboratory, or related operations.

• Demonstrated ability to manage projects and priorities, to meet deliverables and timelines.

• Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills.

Preferred Experience and Skills:

• 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.

• 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 electronic inventory systems, quality management systems, PowerPoint, Excel and Word.

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:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Job Posting End Date:

03/27/2025

*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: R339637