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Job Details

**Senior PV Compliance Manager - Global Biopharmaceutical Company - New Jersey!**

Company: Advanced Clinical Recruitment Ltd
Location: New Jersey
Reference: QA-PV-NJ
Closing Date: 24 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary + Package

Job Summary:

I am currently working with a very well known and exciting Global Biopharmaceutical company, based in New Jersey, who are looking for a Senior PV Compliance Manager to join their team. The Senior Compliance Manager will have significant experience across Quality, and PV Auditing in particular. The company are progressing rapidly not only in the US, but Globally, and have a range of fantastic products on the market at present. There will be a serious possibility for progression within this group.

Requirements:

Job Description

  • Executes complex PV compliance activities and trending activities as well as basic GCP compliance activities
  • Executes mock PAIs which are performed under the responsibility of Pharma QA according to the required company Auditing Standards, against applicable GxP requirements and regulatory requirements and according to the pre-determined auditing plan to achieve a high product quality standard and compliance with all applicable regulations
  • Ensures the required escalation based on the audit outcome
  • Supports upon request PV/GCP inspection readiness of the involved organizations and manages health authority interactions and follow-up
  • Performs audits
  • Supports strategic initiatives for continuous improvement, supports complex audits, in particular leads Data Integrity Audits and CSV Audits upon request. Supports upon request other audits.
  • Involvement in regulatory expectation trending and assessment; sharing of knowledge across Divisions.
  • Training of auditors and site/ organizational inspection management capabilities for GCP/PV. Upon request conducts GCP/PV audits of areas with increased complexity, including “For Cause“ audits utilizing advanced quality assurance techniques. Ensures timely escalation and management of follow-up actions of critical audit observations
  • Verification of CAPA plans and respective improvement projects
  •  Maintains Pharma QA CA procedures and Organizes periodic Quality KPI reviews (when applicable) for the Pharma Compliance Committee, as well as divisional summary report related to compliance activities
  • Ensures inspection readiness in collaboration with the respective organizations
  • Plans and performs audits according to the requirements led down in the respective Quality Module

 

Minimum Requirements

  • Graduate degree in Chemistry, Pharmacy, Microbiology, Engineering or another related science
  • Excellent oral and written English communication skills. Plus point: knowledge of an additional language (e.g. German, French, Italian, Chinese, Spanish)
  • At least 10 years broad experience in Pharmaceutical Industry and or in Regulatory Health Authority
  • Auditing experience in PV, GCP
  • Willingness to travel approx. 40% of the time
  • Quality Systems, Application Integrity Policy Audit, PV, GCP
  • High experience and interaction with major Health Authorities (in particular FDA)
  • Strong interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with colleagues, vendors and customers
  • Sound and practical judgment in the interpretation and application of regulations and standards

 

For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest!

 

Sam Caley - Advanced Clinical Recruitment

+44 (0) 114 270 1741

scaley@acr-uk.com           

LinkedIn Search: Sam Caley Quality Assurance

 

Keywords: QA, Quality Assurance, GCP, GxP, GMP, GLP, Good Clinical Practice, Auditor, Audit, GCP Audits, Clinical Quality Assurance, Lead Auditor, Head or Quality, Senior Auditor, Senior Manager, Management, Audit Strategy, Structure, Home Based, Field Based, Pharmaceutical, Jobs in Pharma, Pharmaceutics, Generics, Specials, CRO, CQA, GCP Auditor, Manager, GCP Manager, London, Remote, Flexible, Central, PV, PVG, GvP, USA, America, NJ, New Jersey, United States

Apply for this job: **Senior PV Compliance Manager - Global Biopharmaceutical Company - New Jersey!**

Contact Information:

Address:  Head Office
Regus 2nd Floor
The Portergate
Eccleshall Road
Sheffield
S11 8NX
England
Tel:  0114 270 1741
Website:  Visit Our Web Site

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