Quality Systems and Compliance Manager

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

Job summary

Padagis is seeking a Quality Assurance (QA) Compliance Manager to oversee validation, audits, data review, CAPA and continuous improvement at our facility. You will lead a team of 5 QA professionals and ensure compliance with cGMP and US FDA requirements across the product lifecycle.

The role combines hands-on quality leadership with strategic oversight, including internal/external audits, change control, investigations and training.

Qualifications

• Bachelor's degree in engineering, science, or closely related field.
• 5+ years in a cGMP manufacturing environment.
• Experience managing internal and external audits (FDA and others).
• Experience applying cGMPs and US FDA requirements in regulated industry.
• Excellent oral and written communication and interpersonal skills.
• Proficient with Microsoft Excel and Word.

Responsibilities

• Oversee site activities related to quality, including audit prep and response (50%).
• Participate in quality events and close unplanned deviation events (20%).
• Conduct training for direct reports and participate in required training (10%).
• Engage in Continuous Improvement initiatives (10%).
• Provide performance feedback and conduct annual reviews (5%).
• Escalate and seek HR assistance as needed (5%).

Skills

Strong communication skills

Attention to detail

Decision making under pressure

Team leadership

Education

Bachelor's Degree in engineering/science or related field

Tools

Microsoft Excel

Microsoft Word

Job description

Padagis is hiring a Quality Assurance (QA) Compliance Manager to ensure the quality and compliance of operational activities occurring at the facility by overseeing validation, internal audit, external audit management and response, data review, product complaints, product lifecycle, change management, investigations, CAPA and continuous improvement. The person selected for this position will lead a team of 5 QA professionals.

This position pays $85,000 - $120,000 USD annually depending on experience and qualifications, in addition to two annual cash incentive bonus plans and a robust and affordable employee benefits program.

Job duties

• Provides oversight to and support of site activities related to quality, including internal and external audit preparation and response activities (50%)
• Participates in quality events and closes unplanned deviation events (20%)
• Conducts training for direct reports and takes part in needed training to perform job function (10%)
• Participates in Continuous Improvement initiatives (10)%
• Provides performance-based feedback to direct reports, including completion of annual performance reviews (5%)
• Seeks assistance on Human Resource issues (5%)

Minimum 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 (like FDA) audits.
• Demonstrated experience applying cGMP's and US FDA laws and requirements in an FDA regulated industry.
• Excellent oral and written communication and interpersonal skills.
• Demonstrated computer literacy, including Microsoft Excel and Word.
• Strong attention to detail and ability to follow written procedures.
• Demonstrated ability to make quality decisions in stressful situations.
• Knowledge and experience in validation concepts (process, method, computer and cleaning), equipment qualification, change management, product lifecycle, master record approval, internal auditing, data review, risk mitigation, investigations and CAPA planning.

Preferred qualifications

• Pharmaceutical industry experience.
• Experience in QA and/or quality management systems (QMS).

Padagis Core Competencies

• Service delivery - Understand who your internal and external customers are, identify their needs, and deliver value above their expectations...
• Active collaboration - Seek opportunities to work together across teams, function, business units, and geographies to seek success...
• Demonstrate agility - Proactively identify changes in our environment and act quickly, leading or embracing change...
• Think differently - Create, develop, and implement new ideas, products, services, or processes that involve introducing something new or significantly improving something that already exists...
• Excellent execution - Achieve outstanding results in all aspects of our organization, including our culture, leadership, strategy, and processes...

About Us

At Padagis our focus is on health care products that improve people's lives. We are a market-leading generic prescription pharmaceutical company that specializes in "extended topical" medications, like creams, foams, mousses, gels, liquids and inhalable products. It's a great time to join our team because we have a high growth trajectory with now more than 1,300 employees across six locations in the United States and Israel. We've already established a successful track record of launching first-to-file and first-to-market generic pharmaceutical products that have helped to make prescription products more affordable for patients and reduce costs for the healthcare system. Our team members work in a dynamic environment where opportunity is built on a foundation of honesty and transparency. Please consider joining our team where great things are happening and you can make a difference.

Qualifications

Experience

• 1 years: Experience leading teams or supervising/managing direct reports. (preferred)
• 5 years: Experience in managing external (FDA) and internal audits in a related cGMP environment. (required)

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.