Quality Systems & Compliance Leader

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

Benefits offered by this job

Annual bonuses

Benefits program

Job summary

Padagis is seeking a Quality Assurance (QA) Compliance Manager to oversee validation, internal and external audits, data review, investigations, CAPA and continuous improvement. You will lead a team of five QA professionals to ensure quality and regulatory compliance at the facility.

The role offers a salary of $85,000 to $120,000 USD per year, plus two annual cash incentive bonus plans and a comprehensive benefits program. Strong communication and cGMP expertise are essential for success.

Qualifications

• Bachelor’s degree in engineering, a science discipline, or closely aligned field.
• 5+ years experience in a cGMP manufacturing environment.
• Experience managing, responding to, and following-up on internal and external audits (FDA preferred).
• Demonstrated experience applying cGMPs and US FDA laws in an FDA regulated industry.
• Excellent oral and written communication and interpersonal skills.
• Demonstrated computer literacy in Excel and Word.

Responsibilities

• Oversee site quality activities including internal and external audit prep and responses.
• Lead QA team of 5 professionals and provide performance feedback.
• Oversee validation, change management, investigations, CAPA, and product lifecycle.
• Review data and ensure compliance with procedures and policies.
• Drive continuous improvement initiatives across operations.

Skills

Audits management

cGMP experience

FDA compliance

Quality decision making

Data review

Communication skills

Education

Bachelor’s degree in engineering/science

Tools

Microsoft Excel

Microsoft Word

Job description

Padagis is seeking a Quality Assurance (QA) Compliance Manager to oversee validation, internal and external audits, data review, investigations, CAPA and continuous improvement. You will lead a team of five QA professionals to ensure quality and regulatory compliance at the facility.

The role offers a salary of $85,000 to $120,000 USD per year, plus two annual cash incentive bonus plans and a comprehensive benefits program. Strong communication and cGMP expertise are essential for success.