Sr. Specialist, Quality Assurance

Job Description

Our 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:

• 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

• Applies data-driven approaches, including the use of analytics dashboards and quality metrics, to detect trends, prioritize audit focus areas, enhance risk-based decision making, and deliver value-added insights that support continuous quality improvement.

• Influences, partners and collaborates with other colleagues within and outside their team 

• Activities may include GCP audits of investigator sites, study level, 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.

• Travel 50% - 70%

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. 

- 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.

Responsibilities relative to the Auditor Resource include:

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

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. 

Notes:

Multiple locations in Europe.

Additional locations in Europe might be considered.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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