Clinical Quality Assurance Manager

Sterling-Hoffman Executive Search Located in: District of Columbia
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JOB DESCRIPTION

Our client, a leading medical device/clinical research company, is looking for a Clinical Quality Assurance Manager to join their team. If you have the required experience and are up for a challenge, this could be a great opportunity for you. Responsibilities include:

1) Perform and report assigned GCP audits of IDE 510k or PMA
2) Prepare timely, well-written audit reports and report observations to auditors, cross-functional representatives and management
3) Obtain and evaluate audit responses or corrective action plans and conduct follow-ups, as needed
4) Perform ad-hoc for cause audits in order to identify or confirm non-compliance and assist with root cause identification
5) Escalate any compliance issues to relevant management personnel
6) Lead and assist Health Authority Inspection Management Team in preparation for and during inspections
7) Evaluate GCP-related issues to assess prioritization and work towards risk mitigation and appropriate resolution
8) Partner with other cross-functional personnel such as Legal, Regulatory and Clinical Operations regarding compliance issue resolution
9) Evaluate aggregate audit observations and trends in order to develop periodic compliance and metric reports and tracking, as requested
10) Maintain high degree of knowledge of global industry expectations, GCP regulations and provide GCP expert advice/guidance to staff in support of GCP operations
11) Act as the representative for assigned studies and actively participate in meetings
12) Participate in compliance projects, process improvements or other investigations and report results to management
13) Perform additional responsibilities, as directed by Quality Management

CRITICAL REQUIREMENTS

  • 1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field
    2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
    3) Recent experience in the medical device / clinical research industry is strongly preferred
    4) Preference will be given to candidates with recent experience in quality assuarance management

    This role is a great opportunity for the right person looking to advance their career with a wonderful company. If you are qualified and think that you are a strong fit for this role, please apply ASAP!

COMPANY INFORMATION

Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

JOB INFORMATION

Seniority Level:
Management / Supervisory
Function:
  Quality
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: