Quality Manager

Kelly Services; Menomonie (WI); On-site; USD 110,000 - 130,000; Full time

Job summary

Kelly Science & Clinical is seeking a Senior Quality Assurance Manager in Menomonie, WI to lead the site QA program in a regulated veterinary/pharma environment.

You will steer QMS, document control, and product release while driving CAPA investigations, audits, and continuous improvement with cross-functional teams. The role emphasizes leadership, regulatory readiness, and strategic quality initiatives.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Engineering, or related field.
• 10+ years of Quality Assurance experience in regulated pharma manufacturing.
• Strong knowledge of FDA cGMP regulations including 21 CFR Parts 11, 210, and 211.
• Experience managing validation programs and Part 11-compliant systems.
• Proven ability to lead quality investigations, CAPAs, change controls, and compliance initiatives.
• Excellent leadership, communication, organizational, and analytical problem-solving skills.
• Advanced proficiency in Microsoft Excel.

Responsibilities

• Lead and maintain site Quality Management Systems (QMS) to ensure FDA cGMP compliance and regulatory requirements.
• Oversee document control, including SOPs, batch records, specs, calibration records, and quality documents.
• Provide QA oversight for manufacturing, laboratory testing, validation, and product release activities.
• Lead investigations involving deviations, CAPAs, customer complaints, change controls, and quality events.
• Review and approve validation plans, protocols, reports, and quality docs.
• Plan and conduct internal quality audits; support supplier qualification and regulatory inspections.
• Ensure processes for product recalls, incoming materials inspections, and regulatory documentation.
• Collaborate with manufacturing and cross-functional teams to strengthen quality systems and drive continuous improvement.
• Promote a culture of quality, accountability, regulatory compliance, and operational excellence.

Skills

Leadership

cGMP knowledge

FDA 21 CFR Part 11

Regulatory compliance

CAPA investigations

Excel proficiency

Education

Bachelor's degree in Life Sciences, Chemistry, Engineering, or related field

Tools

eQMS

Job description

Senior Quality Assurance Manager – Menomonie, WI

Location: Menomonie, WI

Company: Kelly® Science & Clinical

Position: Senior Quality Assurance Manager

Salary: $110,000–$130,000 annually + Bonus

Schedule: Monday–Friday | 8:00 AM–5:00 PM

Take the Next Step in Your Quality Leadership Career with Kelly®!

Kelly Science & Clinical is seeking an experienced Senior Quality Assurance Manager for an exciting opportunity with a growing veterinary pharmaceutical manufacturing facility in Menomonie, Wisconsin!

This is an excellent opportunity for a seasoned quality professional to take a leadership role in an FDA-regulated manufacturing environment. You'll play a critical part in maintaining regulatory compliance, strengthening quality systems, and driving continuous improvement while supporting the production of pharmaceutical products for companion and production animals.

If you're passionate about quality excellence, regulatory compliance, and leading meaningful improvements in pharmaceutical manufacturing, we want to hear from you!

What's a Typical Day as a Senior Quality Assurance Manager?

• Lead and maintain site Quality Management Systems (QMS) to ensure compliance with FDA current Good Manufacturing Practices (cGMP) and applicable regulatory requirements.

• Oversee document control processes, including SOPs, batch records, specifications, calibration records, and other quality documentation.

• Provide quality oversight for pharmaceutical manufacturing, laboratory testing, validation, and product release activities.

• Lead investigations involving deviations, Corrective and Preventive Actions (CAPAs), customer complaints, change controls, and other quality events.

• Review and approve validation plans, protocols, reports, and quality-related documentation.

• Plan and conduct internal quality audits while supporting supplier qualification, regulatory inspections, and external audits.

• Ensure effective processes are established for product recalls, incoming material inspections, and regulatory documentation.

• Collaborate with manufacturing, operations, and cross-functional teams to strengthen quality systems and support continuous improvement.

• Promote a culture of quality, accountability, regulatory compliance, and operational excellence throughout the facility.

What Makes You a Great Fit?

Required Qualifications:

• Bachelor's degree in Life Sciences, Chemistry, Engineering, or a related technical discipline.

• 10+ years of Quality Assurance experience in pharmaceutical, biotechnology, or regulated medical device manufacturing.

• Strong understanding of FDA cGMP regulations, including 21 CFR Parts 11, 210, and 211 .

• Knowledge of ICH guidelines, quality risk management, and pharmaceutical quality systems.

• Experience managing validation programs, electronic Quality Management Systems (eQMS), and Part 11-compliant systems.

• Demonstrated ability to lead quality investigations, CAPAs, change controls, and compliance initiatives.

• Excellent leadership, communication, organizational, and analytical problem-solving skills.

• Advanced proficiency in Microsoft Office, particularly Excel.

• Ability to manage multiple priorities and collaborate effectively in a fast-paced, regulated manufacturing environment.

Preferred Qualifications:

• Previous quality leadership experience within FDA-regulated pharmaceutical manufacturing.

• Experience supporting FDA inspections, regulatory audits, and supplier qualification programs.

• Background in veterinary pharmaceuticals or pharmaceutical dosage-form manufacturing.

• Proven success implementing quality system improvements and driving inspection readiness.

Why Kelly ® Science & Clinical?

At Kelly Science & Clinical, we connect talented professionals with opportunities to make a meaningful impact in the life sciences and pharmaceutical industries.

This opportunity offers:

• Competitive salary: $110,000–$130,000 annually, plus bonus potential.

• Consistent schedule: Monday–Friday, 8:00 AM–5:00 PM.

• Leadership opportunity: Play a key role in shaping quality operations at a growing pharmaceutical manufacturing facility.

• Professional impact: Help ensure the quality, safety, and regulatory compliance of important veterinary pharmaceutical products.

• Career growth: Apply your expertise in a dynamic manufacturing environment focused on continuous improvement and operational excellence.

Compensation is based on several factors, including education, relevant experience, qualifications, and geographic location.

Ready to Lead Quality Excellence?

If you're an experienced Quality Assurance leader ready to make an impact in pharmaceutical manufacturing,

Let Kelly Science & Clinical help you discover what's next in your career.

Kelly® — Connecting great people with great opportunities.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Kelly may use AI-powered tools during the recruitment and hiring process.

For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer.

We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.