Quality Systems & Compliance Leader - QA, Audits & CAPA

Padagis LLC; New Hope (MN); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Cash bonus plans

Benefits program

Job summary

Padagis LLC is hiring a Quality Assurance (QA) Compliance Manager to ensure quality and regulatory compliance across site operations. You will oversee validation, audits, data review, CAPA and continuous improvement while leading a team of 5 QA professionals in Minnesota.

The role requires a strong cGMP background, FDA audit experience, and excellent communication. You will drive risk-based decisions, training, and collaboration with cross-functional teams to maintain product integrity and

Qualifications

• 5+ years of experience in a cGMP manufacturing environment.
• Experience managing, responding to, and following-up on internal and external audits (FDA or equivalent).
• Demonstrated application of cGMPs and FDA regulations in a regulated industry.
• Excellent oral and written communication and interpersonal skills.
• Strong attention to detail and ability to follow written procedures.
• Proven ability to make quality decisions in stressful situations.

Responsibilities

• Oversee QA site activities, including internal/external audit preparation and response.
• Participate in quality events and close unplanned deviation events.
• Train direct reports and provide ongoing job function training.
• Engage in Continuous Improvement initiatives.
• Provide performance-based feedback and complete annual reviews.
• Address Human Resources issues as needed.

Skills

cGMP experience

Audit management

Data review

CAPA planning

Quality leadership

Education

Bachelor's degree in engineering/science

Tools

Microsoft Excel

Microsoft Word

Job description

Padagis LLC is hiring a Quality Assurance (QA) Compliance Manager to ensure quality and regulatory compliance across site operations. You will oversee validation, audits, data review, CAPA and continuous improvement while leading a team of 5 QA professionals in Minnesota.

The role requires a strong cGMP background, FDA audit experience, and excellent communication. You will drive risk-based decisions, training, and collaboration with cross-functional teams to maintain product integrity and