Quality Assurance Manager

11 hours ago

New York, New York, United States #twiceasnice Recruiting Full time

Quality Assurance Manager

Location: Greater Milwaukee Area
(relocation assistance available)

Salary: $115,000-$135,000

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 company's US site is backed by a global parent company that's investing heavily in its American operations, so there's a lot of excitement and growth ahead. You'd 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, you'll have a real impact on the company's ability to expand their market presence. They're 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

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