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Job Details

Quality Manager, R&D Compliance

Company: RBW Consulting
Location: Warren, NJ
Reference: RA-RDCM-WNJ
Closing Date: 10 Mar 17
Type: Full Time
Salary (£): Competitive
Benefits: Competitive Benefits Package

Job Summary:

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!

Requirements:

Quality Manager, R&D Compliance

Warren, NJ

Basic qualifications: 

  • BSc - Science discipline
  • 5 to 10 years of pharmaceutical industry experience with at least 3 to 5 years in GMP auditing   
  • GxP Auditor Certification from an accredited agency or other sanctioned recognized authority
  • Working knowledge of applicable GMP and Regulatory Affairs regulations and guidelines 
  • Experience working in global and multidisciplinary environments 
  • Must be IT systems literate (MS Word, Excel, & Power Point) and be familiar with audit tracking systems (e.g., Trackwise) and regulatory submission management submissions
  • Willingness to travel worldwide, sometimes at short notice
     

Preferred qualifications: 

  • Post-graduate science based degree - Science discipline

Details: 
The role provides oversight and assurance to management for the level of compliance of CHR&D sites and vendors through the assessment processes.

The role also provides support for CHR&D projects, training and ensures that CHR&D sites and vendors are inspection / audit ready.

Plans and conducts global audits independently or as a team in a lead or support role to ensure that robust processes are fully developed to meet the requirements of Good Manufacturing Practices (GMP’s).

Key Responsibilities:

  • Lead GMP audits of Consumer Healthcare R&D(CHRD) facilities & processes and vendors
  • Ensure that senior management is apprised of identified key risks together with their root causes and that appropriate corrective and preventative action plans are prepared and implemented
  • Lead or assist management in performing of risk assessments, planning, co-ordination and conducting of complex assessments
  • Maintain information in audit database system and perform trending / analysis of Findings and Corrective Actions and Preventative Actions (CAPA’s)
  • Review and assess corrective and preventative action plans and ensure timely closure of CAPA’s as per policies and procedures
  • Ensure CHRD sites and vendors are inspection / audit ready and assist management in hosting and supporting Regulatory agency inspections / audits at CHRD facilities
  • Maintain current awareness of the organization, its expectations and strategic direction
  • Represent and promote CHRD Quality both internally and externally through interactions with regulatory agencies, external auditors, professional bodies and associations and customers
  • Build effective working relationships with customers
  • Proactively engage in implementing continuous improvement activities within CHRD.
  • Represent CHRD Quality on due-diligence teams as required
  • Lead or participate in the design and development of departmental or global processes 
  • Maintain current awareness and knowledge of global regulatory requirements, QMS and CH SOPs, and ensure CHRD procedures meets appropriate regulatory requirements

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: Quality Manager, R&D Compliance

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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