QA Manager (Allegan, MI, US, 49010)

Biopharma Careers; Michigan; On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Total Rewards

Forbes recognition 2024

Equal opportunity employer

Job summary

Perrigo is seeking a Quality Assurance Manager to lead quality systems across manufacturing, packaging, and product release. You will partner with Operations, Engineering, Maintenance, Laboratory, and Quality teams to drive a culture of quality and regulatory compliance.

The role focuses on risk-based decision making, audits, and continuous improvement, with responsibility for ensuring products meet FDA standards and company requirements.

Qualifications

• Minimum 8 years in the field with at least 4 years in supervision.
• Bachelor's degree in related discipline required.
• 6+ years in a regulated pharma environment preferred.
• Demonstrated ability in people leadership and quality leadership.

Responsibilities

• Provide quality oversight for site operations and release.
• Lead and develop quality professionals and audits.
• Ensure compliance with cGMP and FDA regulations.
• Manage cross-functional continuous improvement projects.
• Review and approve SOPs, change controls, and validations.
• Support FDA and customer audits and responses.

Skills

Problem-solving

Leadership

Communication skills

Education

Bachelor's degree in related discipline

Job description

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All . We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone , we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Join us on our One Perrigo journey as we evolve to win in self-care.

Description Overview

At Perrigo, we are dedicated to making lives better by delivering high-quality, affordable self-care products that consumers trust worldwide. As the Quality Assurance Manager, you will play a critical leadership role in ensuring the safety, quality, and compliance of our products throughout manufacturing, packaging, and product release operations.

This position provides quality oversight for site operations, driving a culture of quality, regulatory compliance, continuous improvement, and operational excellence. The Quality Assurance Manager partners cross-functionally with Operations, Engineering, Maintenance, Laboratory, and Quality teams to identify risks, resolve quality issues, and implement sustainable improvements that enhance product and process performance.

The successful candidate will lead and develop quality professionals, support regulatory and customer audits, provide risk-based decision making, and ensure compliance with cGMP requirements, FDA regulations, and company standards. This role is ideal for a collaborative leader who is passionate about building high-performing teams while advancing quality systems that protect consumers and support business success.

Scope of the Role

• Strong problem-solving skills, and logical approach based on sound judgment and research
• Sound understanding of cGMP/FDA regulations: CFR and FDA guidance documents related to drug manufacturing (21 CFR 210/211).
• Subject matter expertise that extends beyond the area of responsibility
• Manages support for contract or retail customer technical questions, and/or to provide technical impact or risk assessment
• Promotes development and succession planning for direct and indirect reports within area of responsibility
• Manages and leads cross functional continuous improvement opportunities and projects
• Develops and maintains auditing and release procedures which ensure products released for shipment meet company, customer and FDA standards
• Provides risk assessment over significant Quality events
• Works with operations, laboratory, engineering, and maintenance managers and staff to develop, evaluate and implement action plans which maintain or improve product and process quality
• Partners with Site Quality Leadership to align processes with PMI and OTC objectives
• Reviews and approves Standard Operating Procedure updates, change control, and validation reports.
• Leads and guides others in quality driven initiatives in the continuous support of Quality Improvement
• Final quality approver for standard work instruction (SWI) and standard operating procedures (SOP)
• Supports FDA, customer, internal, and other regulatory audits and responses

Experience Required

• Typically, a minimum of 8 years in the field and 4 years supervisory experience. University Degree or equivalent
• Bachelor's degree within related discipline required
• Six or more years’ experience in a regulated industry, pharma preferred
• Demonstrated ability in areas of people leadership and quality leadership
• Excellent written and oral communication skills

Benefits

We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

Find out more about Total Rewards at Perrigo.

We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law.