Senior Specialist, Clinical Quality Assurance - Remote

Job Description

Our Research & Development Division Quality Assurance (QA) is an independent organization that provides quality focus at each critical stage of the product development life cycle, including post approval marketing, to ensure high-quality, safe, and effective products, contributing to the company mission of improving and saving lives around the world. Our Research & Development Division QA Clinical Quality (CQ) provide independent assurance that our Company ensures the safety, rights, and well-being of participants, while complying with applicable global regulatory requirements through sound processes, procedures, and strategies for ensuring data integrity in our clinical trials.

Primary Responsibilities

• Leads their own specific tasks and responsibilities within a team, prioritizing time and effort towards important deliverables and producing high-quality work
• Contributes to the overall goals of the team by excelling at their individual role and taking initiative to improve their own skills
• Influences, partners and collaborates with other colleagues within and outside their team
• Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g. Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
• Be able to analyze and leverage critical to quality factors to identify potential risks to prepare and perform risked-based audits
• Activities may include GCP audits of investigator sites, suppliers, third party collaborations and due diligence activities.
• In alignment with risk assessments, supports the QAL in the identification of audit substrate for scheduling, as appropriate.
• Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects / products, to the QAL and TA Head.
• Interfaces and provides day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies.
• Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents, and Country Offices (COs) processes against ICH (International Conference of Harmonization), applicable government agency regulations / guidelines, as well as our Company's policies, procedures and industry standards. The QAS should have a comprehensive working knowledge of Quality Assurance, regulations and auditing. Develops and delivers awareness sessions with minimal supervision on various GCP and PV topics internally and externally.
• Promotes standardization of auditing approach within QA.
• Routinely suggests new audit techniques / aids in areas of technical expertise.
• Ensures the work climate / culture within QA, exemplifies our Company's Leadership behaviors

Responsibilities relative to the Auditor Resourcer include

Education

Requirements

Enterprise Leadership Skills

Required Skills

Accountability, Accountability, Adaptability, Audits Compliance, Business Processes, Clinical Documentation, Clinical Quality Management, Clinical Systems Implementation, Clinical Trials, Continual Improvement Process, Data Analysis, Data Quality Control, Detail-Oriented, Deviation Management, Documentations, Employee Training Programs, GMP Auditing, Interpersonal Relationships, Manufacturing Processes, Manufacturing Quality Control, Process Improvements, Product Development, Project Management, Quality Assurance (QA), Quality Assurance Systems {+ 4 more}

Preferred Skills

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.

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

50%

Flexible Work Arrangements

Remote

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

No

Job Posting End Date

12 / 3 / 2025

Requisition ID

R372894

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”.

Salary Range

$104,200.00 - $163,900.00

Benefits

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 .

Application

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.

Legal Statements

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 / ).

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