Quality Systems and Compliance Manager

Padagis; Minnesota; On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Annual cash bonus

Benefits package

Job summary

Padagis is hiring a Quality Assurance (QA) Compliance Manager in Minneapolis to oversee validation, internal and external audits, data review, product lifecycle, CAPA and change management. You will lead a team of 5 QA professionals to ensure quality and regulatory compliance.

The role requires a Bachelor’s degree in engineering or science, 5+ years in a cGMP manufacturing environment, and strong communication skills. On-site with a comprehensive benefits package and incentives.

Qualifications

• Requires Bachelor's in engineering or science
• 5+ years in a cGMP manufacturing environment
• Experience managing audits (FDA & internal/external)
• Strong written and oral communication skills
• Familiarity with validation concepts and CAPA planning

Responsibilities

• Oversee site quality activities including audit prep and response (50%)
• Support handling of deviations and quality events (20%)
• Lead training for QA staff (10%)
• Drive Continuous Improvement initiatives (10%)
• Provide performance feedback and annual reviews (5%)
• Assist HR on issues (5%)

Skills

Quality management

FDA audits

cGMP compliance

Data review

CAPA

Validation concepts

Communication

Education

Bachelor’s degree in engineering/science

Tools

Microsoft Excel

Microsoft Word

Job description

Padagis MN
3940 Quebec Avenue North
Minneapolis, MN 55427, USA

Padagis MN
3940 Quebec Avenue North
Minneapolis, MN 55427, USA

Locations

Showing 1 location Padagis MN
3940 Quebec Avenue North
Minneapolis, MN 55427, USA
Padagis MN
3940 Quebec Avenue North
Minneapolis, MN 55427, USA
+0 more locations less locations

• On-site
• Operations
• Full-Time
• Requisition #: ANALY002039

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