QA Manager
Perrigo Company plc
2 hours ago
Remote friendly (Allegan, MI)
United States
Operations
Overview:
- Ensures company products meet defined quality standards through quality management and oversight of manufacturing, packaging, and QA release teams.
Scope of the Role:
- Strong problem-solving skills and logical, research-based approach
- Sound understanding of cGMP/FDA regulations (21 CFR 210/211)
- Provide subject matter expertise beyond immediate area of responsibility
- Manage support for contract/retail customer technical questions and provide technical impact or risk assessments
- Promote development and succession planning for direct and indirect reports
- Manage and lead cross-functional continuous improvement opportunities and projects
- Develop and maintain auditing and release procedures to ensure shipment releases meet company, customer, and FDA standards
- Provide risk assessment for significant quality events
- Work with operations, laboratory, engineering, and maintenance to develop, evaluate, and implement action plans to maintain/improve product and process quality
- Review and approve SOP updates, change control, and validation reports
- Lead and guide others in quality-driven initiatives supporting continuous Quality Improvement
- Final quality approver for SWI and SOP
- Support FDA, customer, internal, and other regulatory audits and responses
Experience Required:
- Typically 8+ years in the field and 4 years supervisory experience; university degree or equivalent
- Bachelor’s degree in a related discipline required
- 6+ years’ experience in a regulated industry (pharma preferred)
- Demonstrated people leadership and quality leadership
- Excellent written and oral communication skills
Benefits:
- Competitive compensation; benefits for you and your family; career development opportunities (refer to Total Rewards)
Application Instructions:
- Click the APPLY button at the bottom of the application to apply (SAVE only saves profile information).
- Ensures company products meet defined quality standards through quality management and oversight of manufacturing, packaging, and QA release teams.
Scope of the Role:
- Strong problem-solving skills and logical, research-based approach
- Sound understanding of cGMP/FDA regulations (21 CFR 210/211)
- Provide subject matter expertise beyond immediate area of responsibility
- Manage support for contract/retail customer technical questions and provide technical impact or risk assessments
- Promote development and succession planning for direct and indirect reports
- Manage and lead cross-functional continuous improvement opportunities and projects
- Develop and maintain auditing and release procedures to ensure shipment releases meet company, customer, and FDA standards
- Provide risk assessment for significant quality events
- Work with operations, laboratory, engineering, and maintenance to develop, evaluate, and implement action plans to maintain/improve product and process quality
- Review and approve SOP updates, change control, and validation reports
- Lead and guide others in quality-driven initiatives supporting continuous Quality Improvement
- Final quality approver for SWI and SOP
- Support FDA, customer, internal, and other regulatory audits and responses
Experience Required:
- Typically 8+ years in the field and 4 years supervisory experience; university degree or equivalent
- Bachelor’s degree in a related discipline required
- 6+ years’ experience in a regulated industry (pharma preferred)
- Demonstrated people leadership and quality leadership
- Excellent written and oral communication skills
Benefits:
- Competitive compensation; benefits for you and your family; career development opportunities (refer to Total Rewards)
Application Instructions:
- Click the APPLY button at the bottom of the application to apply (SAVE only saves profile information).