Manager, Quality Assurance

Role Summary

In this role, the successful candidate will be responsible for:

• Manages the development, implementation and maintenance of quality assurance systems and activities
• Coordinates lab management activities including new instrument implementations, annual re-qualifications/repairs, and calibrations cross functionally between departments
• Serves as the application administrator for laboratory instruments and software
• Performs risk analysis of laboratory IT applications for applicable system audit trail review
• Performs system audit trail reviews for applications in QA/QC and Manufacturing
• Reviews, revises or writes SOPs
• Assists in new GMP system implementations
• Serve as data integrity champion to identify and enhance systems as required

In addition, the successful candidate will manage generation and review of documents used in Good Manufacturing Practices and manage audits of production and Quality Control areas. May audit raw material vendors and prepare manufacturing documentation for updated filing. May lead investigations and resolve potential product quality issues to improve efficiency. May select, develop, and evaluate personnel to ensure the efficient operation of the function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Minimum Qualifications/Requirements

A minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 8 years experience in the pharmaceutical or other related industry is required. A minimum of 8 years working in a Quality environment with a thorough understanding of cGMPs is a must. A minimum of 5 years previous management experience may be required. Experience with documentation systems and with document review and auditing responsibilities is required. Comprehensive knowledge of current Good Manufacturing Practices and the ability to correctly interpret cGMP minimum standards is a must. Working knowledge in quality sciences, statistics, and computer-based operations is required. Laboratory QC experience is a plus. Strong verbal and written communication skills are required. Must be goal-oriented, quality-conscientious, and customer-focused. Good laboratory compliance and safety practices are a must. Experience working in a team-focused environment is preferred. Excellent computer skills are required. Must be detail oriented. Employee must be able to pass drug screening for employment consideration.

Please note:  This is an on-site role in our Huntsville, Alabama location.

Additional Information

Qualifying employees are eligible to participate in benefit programs such as:

Health Insurance (Medical / Dental / Vision)
Disability , Life & Long - Term Care Insurance
Holiday Pay
Paid-Time Off (PTO)
401(k) Plan Match
Employee Stock Purchase Plan
Wellness Programs
Parental Leave Benefits (in accordance with the terms of the applicable plans) 
For general information on company benefits, please go to https://www.nektar.com/careers