QA Manager
Perrigouk, Pullman, MI, United States
Perrigo Company is dedicated to making lives better by bringing high quality and affordable self‑care products that consumers trust everywhere they are sold. Help us do it.
Description Overview
Ensures that company products meet defined quality standards through Quality management and oversight of the manufacturing, packaging, and QA release teams.
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, or to provide technical impact or risk assessments
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
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.
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. #weareperrigo
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Description Overview
Ensures that company products meet defined quality standards through Quality management and oversight of the manufacturing, packaging, and QA release teams.
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, or to provide technical impact or risk assessments
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
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.
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. #weareperrigo
#J-18808-Ljbffr