Senior QA Compliance Leader – FDA Audits & CAPA

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

Benefits offered by this job

Annual cash incentive

Benefits program

Job summary

Padagis LLC is hiring a Quality Assurance (QA) Compliance Manager to ensure quality and compliance of operations at the facility, overseeing audits, data review, lifecycle, change management, investigations, CAPA, and continuous improvement. The role leads a team of 5 QA professionals.

Salary ranges from $85,000 to $120,000 USD annually, plus two annual cash incentive bonus plans and a robust benefits program.

Qualifications

• Bachelor’s degree in engineering, science, or similar field.
• 5+ years in a cGMP manufacturing environment.
• Experience handling internal and external audits (FDA and others).
• Knowledge of cGMPs and US FDA regulations in regulated industries.
• Strong communication and interpersonal skills.
• Proficient with Microsoft Excel and Word.

Responsibilities

• Oversee site quality activities, audits, validation, CAPA, and continuous improvement (50%).
• Lead QA team of 5; manage deviations and investigations and provide feedback.
• Deliver training to direct reports and participate in required training (10%).
• Participate in Continuous Improvement initiatives (10%).
• Provide performance reviews for team members (5%).
• Coordinate with HR on staffing and related issues (5%).

Skills

Communication

Excel & Word

Attention to detail

Decision making under pressure

Education

Bachelor’s Degree in engineering or science

Job description

Padagis LLC is hiring a Quality Assurance (QA) Compliance Manager to ensure quality and compliance of operations at the facility, overseeing audits, data review, lifecycle, change management, investigations, CAPA, and continuous improvement. The role leads a team of 5 QA professionals.

Salary ranges from $85,000 to $120,000 USD annually, plus two annual cash incentive bonus plans and a robust benefits program.