Director of Quality

Sterling-Hoffman Executive Search Located in: Detroit,  Michigan
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JOB DESCRIPTION

A leading company in the life sciences industry is currently seeking a Director of Quality to join their team. For the right candidate, this is a fantastic opportunity with great growth prospects. Details:

1) Direct and manage all FDA and other regulatory agency activities, including inspections, inquiries, notifications, and other agency associated activities
2) Manage company’s audit program to include internal audits and vendor audits
3) Manage and direct a vendor certification program
4) Set and maintain appropriate policies and procedures to maintain regulatory compliance
5) Develop quality systems to ensure production of quality product and related activities (e.g. Engineering, QC)
6) Approve all documentation used in relation to production of product and its related activities (validation, quality, control testing, engineering, etc.)
7) Lead and provide guidance to the compliance team
8) Identify resources required for effective and efficient operation of the department
9) Recruit qualified personnel, as required, for the department
10) Participate in the management of company and the development and implementation of policies
11) Provide and assist regulatory with ANDA, NDA or IND applications as needed

CRITICAL REQUIREMENTS

  • 1) A university degree is required (preference will be given to those with degrees in a 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 life sciences industry is strongly preferred
    4) Preference will be given to people with recent experience in quality management

    If you think you're a perfect match for this role, you could be just the person to fill the position. 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:
Director / VP
Function:
  Quality
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: