Quality Assurance Director

Sterling-Hoffman Executive Search Located in: Oklahoma
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JOB DESCRIPTION

A leading company in the biotechnology industry is currently seeking an accomplished and highly skilled Quality Assurance Validation Director to lead 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) Develop and implement validation policies and related procedures based on current regulations and industry standards in support of the company's growth and regulatory requirements
2) Provide oversight in the authoring and review of SOPs, protocols, reports and Validation Master Plans for GMP equipment, analytical methods, instruments and computerized systems
3) Perform, author and review documents
4) Implement and manage process validation program, including continued process verification
5) Assist end users in developing User Requirement Specifications and SOPs for GMP systems
6) Understand and apply the understanding of FDA and Quality System Requirements in carrying out duties
7) Train end users on validation policies and requirements to support cGMPs
8) Generate and keep current inventory of all GMP systems and requalification/revalidation schedules
9) Evaluate all GMP Quality Systems utilizing risk assessment approach
10) Plan validation efforts
11) Participate in Change Control and Tech Transfer activities to ensure validation activities are identified to support new and existing client product and company processes
12) Implement, track and maintain group budget
13) Manage validation team members, projects and timelines
14) Track department metrics and provide monthly progress reports to Head of Department
15) Coordinate multiple projects and shifting priorities
16) Mentor, coach, train and evaluate a team of junior and senior validation engineers
17) Lead hiring efforts for team growth and attrition
18) Effectively interact and collaborate with cross-functional departments and clients in order to meet company expectations
19) Prepare and/or present presentations to interdepartmental teams as requested
20) Collaborate with clients and vendors to meet project and company objectives
21) Serve as subject matter expert in all aspects of validation
22) Support internal, client and regulatory audits and inspections and oversee all gaps identified during these events
23) Assist with vendor communications and maintenance/repair scheduling
24) Establish and maintain continuous improvement projects in support of company activities and growth
25) 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 biotechnology industry is strongly preferred
    4) Preference will be given to candidates with recent experience in quality assurance

    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:
  Validation
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: