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Job Details

Manager, GCP Quality Assurance

Company: RBW Consulting
Location: Parsippany, New Jersey
Reference: RA-MQAGCP-PNJ
Closing Date: 10 Mar 17
Type: Full Time
Salary (£): Competitive
Benefits: Competitive Benefits Package

Job Summary:

Our client is a globally recognised, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, the client is privately owned with over 5,700 employees in nearly 60 countries.

Requirements:

Manager, GCP Quality Assurance

Parsippany, New Jersey

Outline:

Our client is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, the client is privately owned with over 5,700 employees in nearly 60 countries.

 In the United States, they identify, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women’s health (obstetrics/gynaecology) and orthopaedics.  In the US, they employ approximately 800 people.

Role Summary:

  • Conducts audits of clinical trial sites, contract research organizations (CRO), suppliers, protocols, investigator brochures (IB) and study reports and reports all audit observations to “sites” and company management
  • Conducts system and process audits as required, e.g. Pharmacovigilance, data management, and safety
  • Provides quality and compliance oversight and promotes quality improvement and relevant harmonization for Clinical Operations according to GQA policy and procedures
  • Maintains GCP regulatory compliance and quality performance within the clients US sites 
  • Responsible for communicating quality issues to area department head(s) and may communicate to executive management, including resource requirements, to maintain QA compliance
  • Prevent and mitigate quality risks which can jeopardize company interests (patient safety, supply continuity, reputation)

 

Responsibilities:

  • Establish audit program for US sponsored clinical trials in cooperation with Corporate Quality Audits
  • Conducts audits of clinical trial sites, suppliers, protocols, and study reports and reports all audit observations to “sites” and management
  • Conducts system and process audits as required, e.g. Pharmacovigilance, data management, and safety
  • Monitor and report audit trends locally
  • Secure peer review of audit reports with GQA
  • Drive a continuous improvement / on-going development mind-set with clinical operation’s management and GQA
  • Manage Quality metrics and key process indicators reporting through monthly quality reporting, local quality reviews board (QRB) and global QRB meetings
  • Execute quality compliance activities: SOP approval, deviation, CAPA and change management, improvement projects
  • Establish and execute GCP training programs
  • Host local regulatory and health authority inspections

 

Requirements:

  • Minimum of a Bachelor of Science degree in Natural Sciences, Pharmacy, or Nursing from an accredited college or university
  • A minimum of 8 years of progressively responsible experience within QA functions with at least 5 year’s GCP auditing experience in clinical research, clinical operations, or clinical QA.  Biotechnology and / or pharmaceutical industry experience is highly preferred over hospital or academic setting
  • Experience and active participation in health authority inspections as well as performing clinical site, readiness inspections
  • Experience in a QA leadership role is preferred
  • Working knowledge of Pharmacovigilance systems and processes is highly preferred
  • MS Office applications and Trackwise
  • Extensive knowledge of cGCP QA and compliance programs
  • Extensive knowledge of ICH E6 and associated FDA.EU GCP regulations is a must with knowledge of ISO14155 for medical device clinical trials preferred
  • Excellent influencing, communication and interpersonal skills, as well as the ability to influence and interact at multiple levels of the organization, manage multiple priorities, and deliver excellent results
  • Experience interfacing with regulatory authorities, notified third party audits and either leading or being in a key participant role
  • Experience with, or direct knowledge of, several quality system elements (e.g. document management, complaint investigation, CAPA, change control, standards and systems management), and a proven track record of participating in cross-functional teams to achieve significant quality and process improvements is required
  • Excellent problem-solver with the ability to make difficult decisions and / or provide sound Quality/Compliance direction with limited supervision
  • Strong background in developing quality objectives through effective quality planning
  • Ability to educate stakeholders, customers and management

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at (646) 586 9087 today!

Apply for this job: Manager, GCP Quality Assurance

Contact Information:

Address:  US Team
Origin Two 106 High Street, Crawley
RH10 1BF
England
Tel:  (646) 586 9087
Website:  Visit Our Web Site

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