Quality and Regulatory Affairs Manager

Sterling-Hoffman Executive Search Located in: Missouri
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Our client, a leading biotechnology company, is currently seeking an accomplished Quality and Regulatory Affairs Manager to join the team. Here is an overview of the role:

1) Align vision and direction of group through key leadership initiatives
2) Provide excellent customer service focus and communication with clients
3) Lead operations and quality processes
4) Oversee the Quality Team’s existing KPIs and create new KPIs for continuous improvement
5) Work autonomously to deliver KPI and objectives communicated by the Director
6) Collaborate with other managerial personnel in formulating, establishing and maintaining the company quality policies and SOPs
7) Engage directly during on-site investigations in order to mitigate any quality-related issues
8) Represent the company in regulatory and quality aspects at external regulatory agencies and conferences
9) Formulate, establish and maintain policies and procedures
10) Maintain an in-depth understanding of business principles, industry dynamics, regulatory environment, market trends and specific operational details related to quality system activities
11) Work with the Operations and Scientific staff to provide quality and regulatory guidance for clients’ projects
12) Maintain quality agreements with external contractors and ensure requirements are met


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


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


Seniority Level:
Management / Supervisory
Preferred Industry Background:
Managing a team of:
Required Travel:

Base Salary:
Other Compensation: