Job Description

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

The QAS will be responsible for the execution of the global Quality Assurance audit activities on assigned studies, products, and Country Offices. This role is responsible for Good Clinical Practice oversight and for assuring the compliance of studies with our Standard Operating Procedures, Policies and all applicable worldwide regulations and guidelines.

Primary activities include but are not limited to:

• Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and external stakeholders and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
• Represents QA and provides guidance from a QA perspective for studies for the assigned Therapeutic Area and applicable countries.
• Supports project team when required, providing Good Clinical Practice compliance advice and guidance to stakeholders 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, from a quality assurance perspective.
• Contributes to the QA strategy and supports QA goals for the aligned studies in the given Region.
• 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 support the implementation of associated risk mitigation strategies.
• In alignment with risk assessments, supports the identification and selection of investigator sites, process, studies, and programs for audit as appropriate.
• Ensures appropriate and timely escalation of quality issues.
• Provides inspection management support as appropriate.
• Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents.

This role can be based remotely from home in any European country that we have an office. Domestic and International travel will be required on a regular basis.

What skills you will need:

In order to excel in this role, you will more than likely have:

• BS/BA degree in a relevant area, Science or Engineering discipline ideal.
• Minimum of five (5) years\xe2\x80\x99 experience in the pharmaceutical/biotechnology industry.
• Demonstrated analytical, problem-solving and communication (oral/written) skills are required.
• Ability to travel, both domestically and internationally.
• Comprehension of drug development life cycle is required. Previous experience in quality assurance and GCP auditing is preferred.

Current Employees apply

Current Contingent Workers apply

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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:

Travel Requirements: 25%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Merck & Co.