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Title : OGN- Senior Specialist Quality Assurance Level III -024
State : Pennsylvania   Date : May 17, 2021
Experience Level :  
Position Type : Senior Specialist Quality Assurance Level III      
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: North Wales, PA  

Job Title: Senior Specialist Quality Assurance Level III

Duration: 8+ months (extendable) contract on W2


Basic Functions & Responsibilities:

In partnership with the client, the Quality Assurance Lead (QAL), the Quality Assurance Auditor (QAA) will support the client’s quality assurance strategy across multiple studies, and/or countries. The QAA will perform audits per the client’s audit/inspection and risk mitigation plans to assure adherence to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GPV), and/or GxP (Good Manufacturing Practice, Good Distribution Practice, Good Laboratory Practice (GLP) in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients. Assesses compliance of clinical investigator sites, vendors, study activities and Country Offices (COs) processes against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as the Client’s policies, procedures and industry standards. The QAA should have a comprehensive working knowledge of Quality Assurance, regulations and auditing. This position is responsible for the execution of the global Quality Assurance (QA) audit activities on assigned studies/products/PV systems/business partners/vendors/Country Offices (CO). This role is responsible for Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of studies and pharmacovigilance systems with the Client’s Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, MHRA, EMA, EU Directives, ICH, and National regulations).

Primary Activities include but are not limited to:
  • Prepares, conducts QA audits, generates audit reports, communicates results to the relevant client QA management and external relevant stakeholders and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
  • Activities include GCP and PV routine and directed (for-cause) audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, business partners, third party collaborations and due diligence activities.
  • Conducts PV audits of PV systems, Country Operations, business partners and vendors Assesses compliance of audit entities against ICH (International Conference of Harmonization), Applicable government agency regulations/guidelines, as well as the Client’s policies, procedures and industry standards. The QAA should have a comprehensive working knowledge of Quality Assurance, regulations and auditing
  • Audit preparation (e.g. review of audit and inspection history, SOPs, industry trends, known non-compliances and relevant quality indicators and intelligence) and notification to key stakeholders, including timely scheduling of audits in consultation with auditees
  • Interfaces with relevant stakeholders, including regulatory, clinical and development sub[1]teams, as appropriate in order to facilitate the execution of the audit.
  • Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL.
  • Provide inspection management support as appropriate. 

Primary skills include but are not limited to:
  • Pharmacovigilance/Clinical/Regulatory Expertise: Broad and in-depth knowledge of the drug development process, Good Clinical Practices (GCP)/Good Pharmacovigilance Practice (GVP) Adverse Events / Safety regulations and guidelines, Awareness of industry trends and hot topics relating to GCP and PV.
  • Business Acumen/Attention to Detail: Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.
  • Applied Therapeutic Area knowledge: Familiarity with multiple therapeutic areas a plus
  • Autonomy: Demonstrated ability to work independently
  • Logic and analytical skills: Uses rigorous logic and methods to solve difficult problems with effective solutions.
  • Communications: Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats.
  • Leadership: Act independently to make key timely decisions with limited oversight by management. Strong ability to motivate teams to embed quality by design through the life cycle of the project.
  • Creative Thinking: Strong ability to operationalize ideas proposed; frequently engages new ideas or ways of doing things and influences creative thinking.
  • Teamwork: Strong interpersonal skills with the ability to work effectively with teams.
  • Influencing: Ability to influence and negotiate with key stakeholders.
  • Decision Making: Demonstrates good judgment and decision making.
  • Time Management: Ability to multi-task and manage time efficiently and effectively.
  • Cultural Agility: Demonstrates ability to work in a culturally diverse environment. 

BS/BA degree in relevant area with significant experience in field and experience in the pharmaceutical industry including experience conducting a broad range of audits.

  • B Pharma exp a must.
  • Microsoft office, Power Pt, Excellent communication skills.
  • Prefer candidates with longer assignments.
  • Team is very small.
  • Primary responsibility will be performing audits and quality oversight for the GCP, GVP and other GxP areas.

Many Thanks,   

Sree Kanth
Recruitment Manager

NewAgeSys, Inc.
Direct: 609-945-1736 Fax: 609-228-4079
600 Alexander Rd, Suite 3-3 
Princeton , NJ 08540 
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