Quality Assurance Senior Specialist – Merck & Co.

Titulo da vaga: Quality Assurance Senior Specialist

Empresa: Merck & Co.

Descrição da vaga: Job Description

In partnership with the Quality Assurance Lead, the Quality Assurance Senior Specialist will support the implementation and management of the Quality assurance strategy across multiple studies and countries. The Quality Assurance Senior Specialist will utilize 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 Quality Assurance Senior Specialist will be accountable for the execution of the global Quality Assurance audit activities on assigned studies, products, and Country Offices. This role is accountable 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 and conducts Quality Assurance audits, generates audit reports, communicates results to the relevant Quality Assurance management and external stakeholders and interacts with various teams to ensure corrective and preventative actions are taken to bring Quality Assurance observations to closure as applicable;
• Represents Quality Assurance and provides guidance from a Quality Assurance 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 Quality Assurance strategy and 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 Quality Assurance assessments and to boost the implementation of associated risk mitigation strategies;
• In alignment with risk assessments, promotes 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.

Main requirements:

• Bachelor’s degree;
• Fluent in English (verbal and written) and excellent communication skills, including the ability to comprehend and present technical information effectively;
• Good comprehension and working knowledge of clinical research, phases of clinical trials, current International Conference on Harmonisation Good Clinical Practice & country clinical research law & guidelines;
• Good comprehension of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines;
• Hands on knowledge of Good Documentation Practices;
• Demonstrated high level of monitoring skill with independent professional judgment;
• Quality Assurance experience within the Clinial Research area will be considered a plus;
• Spanish communication skills will be considered a plus;
• Capable of managing complex issues, works in a solution-oriented manner;
• Effective time management, organizational and interactive skills, conflict management, problem solving skills;
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment;
• Capable of working independently and being self-driven;
• Availability to travel. Expected around 25% of time.

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

Current Employees apply

Current Contingent Workers apply

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: Hybrid, Remote Work

Shift: 1st – Day

Valid Driving License: No

Hazardous Material(s): n/a

Salário:

Local: São Paulo – SP

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