Director of Quality and Regulatory Affairs

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JOB DESCRIPTION

A leading company in the packaging industry is currently seeking a Director of Quality and Regulatory Affairs to take their team to new heights of success. The role will be challenging but also highly rewarding, and this leader will be a key voice in the company. Key duties include:

1) Handle all regulatory compliance programs for the company
2) Develop, implement and maintain the Quality Management System (QMS) to ensure compliance with FDA and other regulatory requirements
3) Direct the internal audit process, including the oversight of GMP audits of the production facility on a regularly scheduled basis, and as necessary
4) Act as a primary contact for all external audits
5) Lead the external audit process, including preparation for ISO 9000 and customer audits
6) Review customer and regulatory requirements to ensure company compliance and to stay abreast of new or updated regulations
7) Act as a primary FDA contact, including completing the annual FDA registration updates and keeping Drug and Device listings current
8) Ensure regulatory compliance on all materials and products
9) Conduct management reviews of QMS
10) Inspect records of finished products for compliance with manufacturing procedures and GMPs to ensure quality and regulatory compliance
11) Analyze audit data and prepare reports for management review and continuous improvement initiatives
12) Perform tests of controls to provide an evaluation of the company’s internal control system, and prepare audit reports for these tests, documenting exceptions to established policies and procedures
13) Perform external quality audits on suppliers to ensure compliance with product specifications
14) Oversee the maintenance of Quality and Audit files for facility
15) Oversee all change control activities to ensure compliance
16) Review all release documents to ensure compliance with SOPs
17) Support company growth initiatives by working with other departments (i.e. Program Management, R&D, Engineering, Operations) to ensure new products, processes, and plans are delivered within established time frames and guidelines
18) Establish, prepare, implement, revise, and maintain policies and procedures related to Quality
19) Provide employee leadership through effective communications, coaching, training, and development
20) Provide leadership for problem resolution to facilitate fast improvements and improved working relationships
21) Ensure compliance with GMP, QSR/ISO, FDA, NSF, NRC, ATF, OSHA, and all other regulatory requirements, in accordance with company policy

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

    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

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: