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Job Details

Director/Senior Director - Clinical Quality Assurance

Company: RBW Consulting
Location: Gaithersburg, Maryland
Reference: RAA-DSDCQA-GMD
Closing Date: 10 Dec 17
Type: Full Time
Salary (£): 100,000+
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 617 982 1238 today!

Requirements:

Director/Senior Director - Clinical Quality Assurance

Gaithersburg, Maryland

Responsibilities:

  • Develop, implement, maintain, monitor, and improve the clinical quality assurance system and function.
  • Assure GxP operations are executed in compliance with applicable guidelines and regulations through quality risk management and risk assessments.
  • Educates and drives a quality risk management culture and manages/escalates the company's compliance risks and visibility to Sr. Leadership.
  • Review and approval of development reports, qualification reports, validation protocols, reports, and amendments, nonclinical protocols and reports, change controls, CAPAs, CAPA plans and deviations.
  • Assure that effective auditing functions are in place and executed to address company requirements for vendor/subcontractor qualification audits (clinical and nonclinical), global clinical investigator site audits, clinical immunology laboratory audits (internal and external),  nonclinical data, internal and external databases (e.g. clinical studies and safety databases), key deliverables/study components  (e.g. study process documents, TMFs, CSRs, tables, listings, ISS, ISE).
  • Administration and oversight for internal and clinical site training, clinical and nonclinical investigations, databases for the quality system, annual reports and quality trending reports, and evaluation of quality events, incidents, and complaints.
  • Provides mentorship, leadership, and prioritization to staff to execute their respective duties.
  • Stays current with related quality legislation, compliance issues, and is an internal company subject matter expert for changes in GXP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents and best industry practices.
  • Effectively cooperates with departments across the company to analyse and resolve technical issues in accordance appropriate quality standards.
  • Supports regulatory inspections as necessary including contributing to the preparation, conduct, and responses to regulatory agencies.

 Requirements:

  • BS/MS in a related science field
  • 15+ years' experience in Clinical Quality Assurance
  • 10+ years' supervisory experience
  • Comprehensive knowledge of drug development process, drug laws, regulations and guidelines
  • Proficient in major regulatory e-submission software, as well as Microsoft Office suite (Word, Excel, PowerPoint)
  • Ability to work independently and within a group setting and to interact effectively with different functional departments
  • Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems
  • Ability to establish and build collaborative relationships with staff, colleagues, and regulatory authorities
  • Demonstrates flexibility in dealing with change and diversity
  • Possesses strong critical and logical thinking

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 617 982 1238 today!

Apply for this job: Director/Senior Director - Clinical Quality Assurance

Contact Information:

Address:  US Team
210 Broadway #201, Cambridge, Massachusetts,
02139
USA
Tel:  (617) 982 1238
Website:  Visit Our Web Site

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