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Director of Quality

Company: Sterling Life Sciences
Location: Sterling
Posted on: September 13, 2020

Job Description:

Sterling-Hoffman Executive Search Located in: Wisconsin

Our client, a leading biopharmaceutical company, is currently recruiting a Director of Quality who will infuse the Quality Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative and growth-oriented vision. Responsibilities include:

1) Guide QA Team to oversee product release, batch record review, approval of production deviations, change controls and investigations

2) Assist QC Team to oversee all cGMP testing of raw materials, product release, clean utility and environmental monitoring testing

3) Review and approve all QC related investigations both internal and external laboratories

4) Interface with supplier and customer quality representatives concerning problems with quality control and ensure that effective corrective action is implemented

5) Work with the Project teams to represent the quality organization, conduct risk assessments and introduce best practices into the quality management systems across the company

6) Guide the quality unit to include manufacturing record review, raw data review and final drug product AQL activities

7) Lead quality validation operations, including protocol and final report review to ensure adherence to industry requirements

8) Supervise QC of Chemistry and Microbiology testing in support of all company’s manufacturing locations

9) Drive technical troubleshooting, operational improvements and efficiency improvements

10) Report results to executive team as a sitting member of the executive quality council

11) Work directly with regulatory agencies, including the FDA and EMA

12) Ensure all QC functions and testing are being performed according to FDA, EMA, ICH and other international regulations, as deemed necessary

13) Work directly with clients to negotiate quality agreements

14) Support regulatory information requests from customers as it pertains to QC

15) Support Operations and Project management staff

16) Work closely with internal QA and QC teams

17) Interact with all departmental staff and other departments at all levels

18) Perform other duties as assigned

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 biopharmaceutical industry is strongly preferred

4) Preference will be given to candidates with recent experience in quality management

For the right leader, this is a wonderfully rewarding role with tremendous growth prospects. If you are qualified and think you're a strong fit for this role, please apply ASAP. We thank all applicants, but only candidates who meet our client's criteria will be contacted.

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

Keywords: Sterling Life Sciences, Sterling , Director of Quality, Other , Sterling, Virginia

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