Quality Assurance Manager

Quality Assurance Manager

Location : Greater Milwaukee Area (relocation assistance available)

Salary : $115000-$135000

Benefits : Medical Dental Vision Life 401k Holidays Vacation

Job Type : Full-Time

Typical Hours : M-F; 8 AM 6 PM

Start Date : ASAP

Sponsorship is not available

Quality Assurance Manager (pharmaceutical and / or biotechnology quality exp. req.) Description

Our client a growing pharmaceutical manufacturing company is seeking a Quality Assurance Manager to join their team in the Greater Milwaukee Area. Reporting to the Director of Quality this hands-on role is responsible for ensuring that quality standards regulatory requirements and customer expectations are consistently met through strong systems precise documentation and proactive compliance oversight. The companys US site is backed by a global parent company thats investing heavily in its American operations so theres a lot of excitement and growth ahead. Youd be joining a close-knit team of 40 in Wisconsin which means your days will have plenty of variety. From managing supplier relationships and leading audits to helping scale their processes for future growth youll have a real impact on the companys ability to expand their market presence. Theyre seeking someone who can adapt as processes and systems evolve and who can translate complex technical information into clear understandable insights for the entire team. If you have a well-rounded background in QA with experience overseeing GMP requirements and bring an approachable patient demeanor this role could be an excellent fit. With our client you will not be another cog in the machine. Your contributions will be visible and valued across an organization with a strong international footprint.

Quality Assurance Manager (pharmaceutical and / or biotechnology quality exp. req.) Responsibilities

Establish uphold and continuously enhance company-wide quality and compliance standards

Monitor internal systems to ensure alignment with regulatory and customer requirements

Oversee supplier and partner quality programs including audits qualifications etc.

Manage compliance processes such as deviations investigations and product release activities

Support regulatory submissions and interactions with external agencies and certification bodies

Lead audit programs ensuring timely reporting follow-up and corrective actions

Author evaluate and approve equipment IQ / OQ protocols

Supervise QA documentation including SOPs batch record reviews and material approvals

Promote adherence to cGMP FSMS and other food safety or nutraceutical quality systems

Respond to customer quality concerns complaint investigations and product inquiries

Collaborate across departments to maintain a culture of continuous improvement

Quality Assurance Manager (pharmaceutical and / or biotechnology quality exp. req.) Qualifications

Current experience within pharmaceutical or biotech required

Minimum 5 years of quality assurance experience in a GMP-regulated environment required

Strong knowledge of change control deviation and CAPA processes required

Supplier management experience required

Required Experience :

Manager

Key Skills

Quality Assurance,FDA Regulations,Food Industry,Food Safety Experience,ISO 9001,Quality Systems,Food Processing,Quality Control,Quality Management,QA / QC,Selenium,HACCP

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 115000 - 135000