Director of Regulatory and Quality

Sterling-Hoffman Executive Search Located in: Idaho
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JOB DESCRIPTION

If you are looking to work with a well-established company - one of the top names in the industry - you should not let this opportunity pass by. However, for this Director of Regulatory and Quality role, you must be someone who is experienced and passionate about regulatory and quality management.

1) Develop and implement strategies and projects to optimize regulatory performance
2) Complete regulatory and other related submissions
3) Identify, lead and support QA initiatives for internal quality
4) Develop, implement and maintain the quality management system to ensure compliance with FDA and other regulatory requirements
5) Create strategic plans for quality improvements in order to increase efficiency and overall quality assurance
6) Resolve issues potentially affecting product quality / compliance
7) Evaluate and develop techniques designed to maintain awareness of SOPs and cGMPSs
8) Audit records of finished products for compliance with manufacturing procedures
9) Oversee the maintenance of quality system records for facility and all change control activities to ensure compliance
10) Interact with direct reports to resolve quality issues
11) Establish, prepare, implement, revise and maintain policies and procedures related to quality
12) Oversee corrective and preventive action program

CRITICAL REQUIREMENTS

  • 1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
    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 people have recent experience in regulatory and quality management

    This is an amazing opportunity for someone who isn't afraid of rolling up their sleeves to get things done and has a great attitude. Our client believes in adding value to each and every thing they do and are looking for someone with similar values.

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:
Director / VP
Function:
  Quality
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation:
A superb base salary and bonus structure are available; compensation is commensurate with experience and will be discussed with qualified candidates only.