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 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 Companys 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 Companys Leadership behaviors

Responsibilities relative to the Auditor Resourcer include:

• Support advance and drive the Clinical Quality capacity planning and assignment of GCP audits

• Lead our Research & Development Division QA Clinical Quality audit planning processes

• Implement annual audit programs into the Veeva Vault QMS system

• Perform routine QC checks and follow up with Clinical Quality and other QA functional groups on key parameters in the Veeva Vault QMS system

• Resolve scheduling conflicts for quarterly audit assignments to ensure Clinical Quality reaches its annual planned audits

• Collaborate across our Research & Development Division QA to continuously improve business processes as it relates to the new systems and tools

• Collaborate with our Research & Development Division IT organization on exploration of technologies to solve our Research & Development Division QA business needs

• Collaborate with our Research & Development Division Analytics & QA Analytics and Tech/System teams as needed on the continued evolution of data analytics and use of metrics

• Understand applicable regulations technology and processes to work effectively with our Research & Development Division QA functional areas and subject matter experts

• Support the project lead/project manager for activities which may include (but are not limited to) the following:

• Drive the development and/or improvement of technology solutions related to document audit and quality issues management

• Develop and/or revise standard operating procedures as related to QA systems and supporting practices

• Participate in continuous process improvement initiatives as related to QA systems and supporting practices

• Analyzing and trending data from audits across our Research & Development Division

• Support the development of best practices and resources related to current industry initiatives

Education

• BS/BA degree or equivalent and/or experience in a relevant field along with proficiency in the primary activities and essential skills required for this role.

Requirements:

• Good Clinical Practice (GCP) experience required.

• 3 years of GCP experience preferred.

• Good oral and communication skills.

• Good time management skills.

• Ability to work independently.

• Ability to travel up to 50% of time.

Enterprise Leadership Skills

• Ownership and Accountability - Taking ownership; setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed

• Execution Excellence - Taking prompt action to accomplish work goals per compliance standards; taking action to achieve results beyond what is required; being proactive.

• Emotional Intelligence - Meeting the personal needs of individuals to build trust encourage two-way communication build allyship and strengthen relationships

• Networking and Partnerships - Building partnerships; developing and leveraging relationships within and across work groups to achieve results.

• Coaching and Development- Building self-insight; demonstrating an awareness of own strengths and development needs as well as the impact of own behavior on others; modifying behavior based on self-awareness to improve impact.

• Talent Growth - Embracing continuous learning; actively identifying new areas for growth; regularly creating and taking advantage of learning opportunities; using newly gained knowledge and skills on the job and learning through their application.

• Diversity and Inclusion Valuing differences; working effectively with individuals of diverse cultures interpersonal styles perspectives motivations or backgrounds; seeking out and including unique abilities insights and ideas from a diverse mix of individuals.

EligibleforERP

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

Current Contingent Workers apply HERE

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 if you need an accommodation during the application or hiring process.

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 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:

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 anothers thinking and approach problems collectively.

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 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 salary range for this role is

$104200.00 - $163900.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

*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.

Required Experience:

Senior IC