Associate Director, Quality Assurance Pharmacovigilance
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The Quality Assurance Specialist (QAS) will support the implementation and management of the Quality Assurance strategy relating to the Merck and MSD pharmacovigilance (PV) system across Merck Headquarters (HQ) and affiliate organizations. The QAS will utilize audit and inspection intelligence and risk mitigation plans to assure the appropriateness and effectiveness of implementation and operation of the Merck and MSD pharmacovigilance system, such that it is compliant with global legal PV requirements, prevents harm from adverse reactions, contributes to the protection of patients’ and public health and promotes safe and effective use of Merck’s and MSD’s medicinal products.
The QAS position is responsible for the execution of global Quality Assurance (QA) audit activities for assigned PV systems, Country Operations (CO), business partners and vendors. This role is responsible for PV and Good Clinical Practice (GCP) oversight, and for assuring quality and compliance of pharmacovigilance systems with Merck Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations).
- Interfaces with relevant stakeholders to provide Pharmacovigilance and QA expertise, compliance advice and guidance, to promote continuous quality improvement and effective quality controls
- In collaboration with the QA, PV Lead, actively contributes to quality management oversight, in the development of and implementation of risk assessments and quality oversight initiatives
- Proactively identify, analyze and leverage quality indicators and data to identify potential risks and trends with a view to
- completing risk-based QA assessments
- performing root cause analyses
- identifying opportunities for quality improvements
- supporting the implementation of associated risk mitigation strategies
- implementing principles of knowledge-based auditing
- Ensures appropriate and timely escalation of quality issues, including critical audit findings, potential misconduct or issues of significant deviation with PV systems/processes/projects
- In alignment with risk assessments, supports the identification of audit targets for scheduling
- Conducts wide range of GPVP (Good Practices Quality Guidelines and Regulations) audits, in accordance with QA risk-based processes, specifically:
- Conducts PV audits of PV systems, Country Operations, business partners and vendors
- May conduct GCP audits, as required and determined appropriate based on knowledge and experience
- Assesses compliance of audit entities against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as Merck policies, procedures and industry standards. The QAS should have a comprehensive working knowledge of Quality Assurance, regulations and auditing
- Prepares and conducts QA audits, generates audit reports, communicates results to the relevant QA management and relevant stakeholders, and interacts with applicable stakeholders to ensure corrective and preventative actions are taken to address QA findings
- Perform independent verification of the completion of applicable corrective and preventative actions taken in response to audit findings, and as appropriate, perform checks to ensure the effectiveness of actions taken to improve pharmacovigilance systems and processes
- Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally.
- Promotes standardization of auditing approach within QA, as well as proposing new audit techniques/aids in areas of technical expertise
- Develops and delivers awareness sessions with minimal supervision on various PV and GCP topics
- Acts as a strong technical resource and is called upon to resolve PV/GCP issues based on knowledge of relevant PV/GCP regulations (global and local) and guidelines as well as applicable standard operating procedures (SOPs)
- Provide inspection management support as appropriate
- Design and actively participate in special assignments on various project teams and work streams
- Provides training and mentorship to less experienced members of QA staff
- Bachelor’s degree or equivalent in relevant area
- A minimum of 8 years of relevant experience in the pharmaceutical industry (i.e., drug development, clinical and/or non- clinical research, regulatory compliance, clinical study monitoring or Pharmacovigilance).
- A substantial work history in pharmacovigilance and QA oversight activities.
- Previous Quality Assurance experience conducting a broad range of audits.
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Job: Quality Assurance
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck