Manager, Quality Assurance

Edison, NJ

Contract

apply now

OVERVIEW

Now hiring for a hungry Manager, Quality Assurance of Clinical Safety Pharmacovigilance who has a generous spirit, is committed to creating change and is committed to the pharmaceutical industry. The Manager, Quality Assurance position is located in Edison, New Jersey, and will be responsible for managing an audit schedule that will assure clinical studies (Phase I through IV) and the systems and processes of the Clinical Safety Pharmacovigilance (CSPV) group and its partners, affiliates, and vendors are compliant with regulatory requirements. 

RESPONSIBILITIES

  • Performs and manages all types of audits in the audit program of Clinical Safety Pharmacovigilance 
  • Generates and updates audit program documentation for assigned projects, conducts audit related activities from preparation to writing and distribution of reports
  • Collaborates with Consultant Auditors to ensure the performance of audit activities and assists in the review of Consultant Audit Reports 
  • Verifies, assesses, and tracks CAPA documentation and commitment implementation
  • Evaluates impact of CAPA implementation
  • Interprets relevant regulations and applies these to practical Clinical Research and Development and Clinical Safety Pharmacovigilance program
  • Supports intelligence collection, communicates, and presents findings on relevant topics for training
  • Collaborates with global QA teams in developing and implementing CSPV, Good Clinical Practices, and Good Laboratory Practices QA objectives and schedules for audits of investigator sites, CROs, bio-analytical labs, etc. 
  • Acts as an internal consultant by liaising with departments regarding global conformance with CSPV/GCP/GLP requirements, and internal standards, and the pro-active integration of quality and process improvement 
  • Supports CSPV/GCP/GLP regulatory inspections (internal) at facilities, investigator sites, CROs, and bio-analytical laboratories for US submissions and investigator sites
  • Prepares, coordinates, and tracks document requests, responses, and supporting documentation during inspections, and verifies implementation of responses after inspections

EXPERIENCE

  • A minimum of five years of experience with a minimum of two in the CSPV QA area

EDUCATION

  • Bachelor’s Degree in scientific, health care, or related discipline or background in Medical Health Profession (RN, Medical technologist, etc.)

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

847-267-1176