Job Description

Support the implementation and management of the Quality assurance strategy across multiple studies, and/or countries. 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.

This position is responsible for the execution of the global Quality Assurance audit activities on assigned studies, products, vendors and Country Offices. 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, policies, and all applicable worldwide regulations and guidelines.

Primary activities include, but are not limited to:

Prepares and 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;Activities may include Good Clinical Practice (GCP) and Pharmacovigilance (PV) routine and directed audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, third-party collaborations and due diligence activities; Will represent QA as a single point of contact and provides QA guidance for studies;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;Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice, Pharmacovigilance and QA expertise;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;Actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements);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;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 Quality Assurandce Lead and Therapeutic Area Head;Interfaces and provides day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies;Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally;Provide inspection management support as appropriate;Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents, and Country Offices processes against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as our Company's policies, procedures and industry standards;Promotes standardization of auditing approach within QA;Routinely suggests new audit techniques/aids in areas of technical expertise;Design and actively participate in special assignments on various project teams and work streams as determined by QA management.

Main requirements:

Bachelor's degree or higher (or equivalent qualifications) in pharmacy or a life-science subject;Broad and in-depth knowledge of the drug development process, Good Clinical Practice guidelines, and applicable regulations is essential;Experience as a clinical quality professional is required;Experience as a clinical quality auditor will be considered a plus;Business Acumen and Attention to Detail.Logic and analytical skills using rigorous logic and methods to solve difficult problems with effective solutions;Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats;Creative Thinking engaging new ideas or ways of doing things and influences creative thinking;

  

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. 

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Current Contingent Workers apply HERE

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:

25%

Flexible Work Arrangements:

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

n/a

Requisition ID:R270167