Associate Director, Clinical Quality Assurance (Remote)

In partnership with the Quality Assurance Lead (QAL), the Quality Assurance Specialist (QAS) will support the implementation and management of the Quality assurance strategy across multiple studies, and/or countries. The QAS will utilize audit and inspection intelligence and risk mitigation plans to assure adherence to Good Clinical Practice (GCP) in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients.

The QAS position is responsible for the execution of the global Quality Assurance (QA) audit activities on assigned studies/products/vendors/Country Offices (CO). This role is accountable for Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of studies with our Company's Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines (e.g., United States FDA, European Union Directives, ICH, and National regulations). Primary activities include, but are not limited to:

Primary Responsibilities:

• Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to promote the implementation of associated risk mitigation strategies.
• In alignment with risk assessments, supports the identification of audit substrate for scheduling, as appropriate.
• Serves as a member of the project team with participation in the applicable forums, providing GCP compliance advice and guidance to customers, to achieve continuous quality improvement and effective quality controls.
• 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.
• Interfaces and provides day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies.
• Prepares, conducts Quality Assurance (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.
• Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally.
• Be able to analyze and leverage quality indicators and data to identify potential trends and risks and perform root cause analyses to enable principles of knowledge-based auditing within respective TA and/or region.
• Routinely suggests new audit techniques/aids in areas of technical expertise.
• Support Significant Quality Issues management for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions. 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.
• In partnership with the QAL, actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements).
• Activities may include GCP and PV routine and directed audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, third-party collaborations and due diligence activities.
• Promotes standardization of auditing approach within QA.
• Will represent QA as a single point of contact and provides QA guidance for studies in a certain Therapeutic Area (TA) or in certain countries.
• Ensures the work climate/culture within QA, exemplifies our Company's Leadership behaviors.
• Provide inspection management support as appropriate.
• Acts as a strong technical resource and is called upon to resolve GCP/PV issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP, PV regulations and guidelines as well as local regulations.
• Contributes to the QA strategy and supports QA goals for the aligned studies/countries in a given TA/Region.
• Provides training and mentorship to less experienced members of QA staff.
• Design and actively participate in special assignments on various project teams and work streams as determined by QA management.
• Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice, Pharmacovigilance and QA expertise.

Education Minimum Requirements:

• BS/BA degree in a relevant area with 8+ years of experience in the pharmaceutical industry.

Preferred Experience and Skills:

• GCP QA site audit experience.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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In 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 separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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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.

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U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday – plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

Under New York City, 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:

$118,640.00 - $186,800.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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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:

25%

Flexible Work Arrangements:

Hybrid, Remote Work

Shift:

Not Indicated

Valid Driving License:

Yes

Hazardous Material(s):

N/A

Requisition ID:R243326