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Director Quality Assurance/Regulatory Affairs
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| Description |
Summary:
Develops, implements, and coordinates product assurance program to prevent or eliminate defects in new or existing products by performing the following duties.
Duties:
- Leads the Quality Systems and Regulatory Affairs (QSRA) function. Determines organizational objectives and Quality System updates required to support continued aggressive growth in a compliant and cost-effective manner.
- Responsible for regulatory compliance with FDA.
- Responsible for interactions with applicable regulating agencies and business partners regarding product compliance.
- Management Representative responsible for implementing and maintaining a compliant Quality System per FDA; represents company during regulatory agency audits and inspections.
- Promote organization’s growth and adherence to industry standards in regard to product assurance, validations, document and data controls, supplier management, etc.
- Oversee the Quality Assurance function with the responsibility to ensure compliance within the context of business goals and objectives.
- Function includes CAPA, comprehensive audit program, complaint investigation, and document control.
- Monitor and supervise Quality Control function with the responsibility to ensure compliance with cGMP
- Monitor the review of all data obtained during all quality assurance activities to ensure consistency with company policies and procedures.
- Enforces inspection activity for product throughout production cycle.
- Directs and manages the process to perform in-house audits and audits of outside contractors, both AccuMed and QPharma facility
- Conducts annual product reviews and total quality programs
- Review and revise SOP’s as needed
- Bring together staff of different disciplines and driving the group to plan, formulate and agree comprehensive quality procedures, persuading reluctant staff to change their way of working to incorporate quality methods.
- Analyzes, evaluates, and presents information concerning factors such as production capabilities, manufacturing problems, business situations, economic trends, and design and development of new products for consideration by the management.
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| Requirements |
- Masters or other advanced degree in scientific discipline.
- 10+ years experience in a Quality and/or Regulatory management position preferably in OTC manufacturing.
- Strong process quality skills.
- Excellent managerial skills; includes project management, problem-solving, written and verbal communications, and organizational abilities.
- Excellent teamwork, leadership, influencing, and coordinative skills; must be able to work with diverse teams to achieve results.
- The ability to train employees and raise process improvement skills and overall quality standards across multiple functions.
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| Location |
New Jersey |
| Salary |
$85,000 - $125,000 |
| Contact Name |
Chris |
| Contact Email |
chris@prestigepersonnel.com |
| Contact Phone |
610-995-1066 |
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