QUALITY ASSURANCE MANAGER

Biotechnology & pharmaceutical Quality assurance manager

QUALITY ASSURANCE MANAGER.

durham, north carolina Posted 6 days ago Closes 7/31/2026 Job details Summary Spherion $115,000 - $150,000 per year Permanent 8:00 AM - 5:00 PM Industry biotechnology & pharmaceutical (Healthcare Support Occupations) Reference number S_175630 The Quality Assurance Manager ensures consistent quality standards, compliance and continuous improvement as well as provides hands-on support to ensure the site meets regulatory requirements, customer expectations and organizational goals.

Responsibilities:

? Establish and maintain QA policies, procedures and SOPs. ? Lead quality review meetings, ensuring alignment on metrics, issues and improvement plans. ? Ensure site compliance with relevant regulatory requirements. ? Lead internal and external audits across the site network. ? Maintain readiness for regulatory inspections, support site-level inspection teams and be QA Lead for regulatory inspections. ? Oversee CAPA, deviations management, change control and document control process at the site. ? Monitor and analyze quality metrics across the network to identify trends and areas of risk. ? Support root-cause analysis and problem-solving activities. ? Lead or support quality improvement projects, ensuring consistency in tools, methods and documentation. ? Facilitate training programs on quality principles, processes and compliance expectations. ... ? Identify and assess quality risks across the site network and develop risk mitigation strategies. ? Maintain network-wide risk registers and ensure proactive follow up on mitigation activities.

Working hours:

8:00 AM - 5:00

PM Skills:

Preferred certification:

Quality Auditor Education:

Bachelors Experience:

7-10 years

Qualifications:

? Strong ability to motivate company personnel to adhere to quality policies and procedures. ? Solid independent thinking ability and demonstrated ability to discern multiple viewpoints. ? Good working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations. ? Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training and CAPA programs) ? Good analytical skills with the ability to evaluate data trends for lessons learned, required action, etc. ? Demonstrated ability to conduct root cause analysis and to prepare written remediation plans. ? Demonstrate process auditing and improvement skills and aptitude. ? Demonstrate ability to develop effective procedures and to write clear, consistent, thorough SOPs. ? Excellent verbal and written communication skills. and email sarahfinnerty@spherion.com with your interest. Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion.

Equal Opportunity Employer:

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Spherion, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact Callcenter@spherion.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Spherion offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). Show more key responsibilities ? Establish and maintain QA policies, procedures and SOPs.? Lead quality review meetings, ensuring alignment on metrics, issues and improvement plans.? Ensure site compliance with relevant regulatory requirements.? Lead internal and external audits across the site network.? Maintain readiness for regulatory inspections, support site-level inspection teams and be QA Lead for regulatory inspections.? Oversee CAPA, deviations management, change control and document control process at the site.? Monitor and analyze quality metrics across the network to identify trends and areas of risk.? Support root-cause analysis and problem-solving activities.? Lead or support quality improvement projects, ensuring consistency in tools, methods and documentation.? Facilitate training programs on quality principles, processes and compliance expectations. ? Identify and assess quality risks across the site network and develop risk mitigation strategies.? Maintain network-wide risk registers and ensure proactive follow up on mitigation activities. experience 7-10 years skills Preferred certification: Quality Auditor qualifications ? Strong ability to motivate company personnel to adhere to quality policies and procedures. ? Solid independent thinking ability and demonstrated ability to discern multiple viewpoints. ? Good working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations. ? Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training and CAPA programs)? Good analytical skills with the ability to evaluate data trends for lessons learned, required action, etc. ? Demonstrated ability to conduct root cause analysis and to prepare written remediation plans. ? Demonstrate process auditing and improvement skills and aptitude. ? Demonstrate ability to develop effective procedures and to write clear, consistent, thorough SOPs. ? Excellent verbal and written communication skills. education Bachelors share this job. send via e-mail print it Get in touch. We are here to help you with your questions. FS Finnerty, Sarah sarahfinnerty@spherion.com