Quality Systems and Compliance Manager

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 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%)
• 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:

Since its beginning, Padagis has been undergoing the process of identifying what we believe will lead to the success of our organization in a competitive landscape. To that end, we have developed a set of five “core” competencies. We strive to bring employees on board the journey with us who exemplify these key 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.

What’s Next:

At Padagis a real recruiter AND the hiring manager will review your application, not just a bot. This means we pay special attention to each application submitted for the position. While it could take a couple of days for us to get back with you, please know that we appreciate you applying for the open position and ask that you monitor your email for updates.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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:

Since its beginning, Padagis has been undergoing the process of identifying what we believe will lead to the success of our organization in a competitive landscape. To that end, we have developed a set of five “core” competencies. We strive to bring employees on board the journey with us who exemplify these key 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.

What’s Next:

At Padagis a real recruiter AND the hiring manager will review your application, not just a bot. This means we pay special attention to each application submitted for the position. While it could take a couple of days for us to get back with you, please know that we appreciate you applying for the open position and ask that you monitor your email for updates.

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.