Senior Director of Quality Assurance and Regulatory Affairs

Sterling-Hoffman Executive Search Located in: New Jersey
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JOB DESCRIPTION

A leading pharmaceutical company is currently seeking a Senior Director of Quality Assurance and Regulatory Affairs to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Key duties include:

1) Establish and manage an on-going corporate quality assurance program
2) Comply with cGMP and all other governmental regulations and company’s standards
3) Lead routine cGMP and FDA inspections
4) Implement quality metrics and KPIs for the Quality staff
5) Provide guidance and overview timely resolution of investigations and deviations
6) Manage and train the Corporate Compliance staff
7) Ensure that all new and revised corporate SOPs are maintained
8) Ensure that all systems are validated and updated, as appropriate
9) Understand pharmaceutical regulations and their impact on contract manufacturing, development, analytical and quality operations
10) Manage and direct the Quality Assurance functions
11) Interact with governmental agencies and customer representatives, as required
12) Conduct and document investigations for customer complaints, deviations and failures
13) Ensure possible corrective actions are implemented in a timely manner
14) Establish and maintain on-going training programs
15) Review analytical data used for release of finished products
16) Approve certificates of analysis for finished products
17) Release or reject raw materials and finished products
18) Monitor sample and maintain the quality of purified water systems
19) Conduct quality meetings on a quarterly basis
20) Participate in the Corporate Management Team
21) Support and enforce all corporate standards and policies
22) Develop and initiate new systems and procedures, as needed
23) Conduct internal audits to assess overall state of compliance of laboratory procedures and practices
24) 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 pharmaceutical industry is strongly preferred
    4) Preference will be given to candidates with recent experience in quality assurance and regulatory affairs

    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!

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: