Quality and Regulatory Affairs Manager

Sterling-Hoffman Executive Search Located in: South Carolina
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JOB DESCRIPTION

Our client, a leading pharmaceutical company, is currently seeking an accomplished Quality and Regulatory Affairs Manager to join the team. Here is an overview of the role:

1) Prepare work plans and provide regulatory affairs direction to lower-level resources
2) Create schedules and work plans for monitoring, compiling and submitting filings that are consistent with company standards
3) Participate in the modification, development and implementation of company policies and practices for regulatory affairs that affect subordinate resources
4) Direct the activities of resources, both internal and outside contractors and vendors with similar technical or functional responsibilities
5) Implement operational and strategic policies and directives
6) Develop functional processes for area managed
7) Actively measure, monitor, report and act upon KPIs related to the effectiveness of the quality management systems
8) Ensure KPIs are embedded within the lines of code, including through the quality council process
9) Review and implement processes that meet company’s quality management system requirements
10) Ensure that quality alerts and regulatory intelligence are evaluated and action plans are implemented

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 pharmaceutical industry is strongly preferred
    4) Preference will be given to candidates with recent experience in regulatory affairs and quality 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: