Quality Systems and Compliance Manager

Metadata: Full-time position located at the facility.

About the role

Ensure the quality and compliance of operational activities by overseeing validation, internal and external audit management, data review, product complaints, product lifecycle, change management, investigations, CAPA, and continuous improvement. This role leads a team of 5 QA professionals.

Responsibilities

• Provides oversight and support of site activities related to quality, including internal and external audit preparation and response (50%)
• Participates in quality events and closes unplanned deviation events (20%)
• Conducts training for direct reports and participates in needed training to perform job functions (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%)

Requirements

• 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 (e.g., 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)

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, functions, business units, and geographies to achieve 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 introduce something new or significantly improve existing ones
• Excellent execution: Achieve outstanding results in all aspects of our organization, including culture, leadership, strategy, and processes

About Us

Padagis is a market-leading generic prescription pharmaceutical company specializing in “extended topical” medications, such as creams, foams, mousses, gels, liquids, and inhalable products. We focus on healthcare products that improve people’s lives. With over 1,300 employees across six locations in the United States and Israel, Padagis has a high growth trajectory and a successful track record of launching first-to-file and first-to-market generic pharmaceutical products. Our team works in a dynamic environment built on honesty and transparency.

Pay

$85,000 - $120,000 USD annually, depending on experience and qualifications, plus two annual cash incentive bonus plans.

Benefits

Robust and affordable employee benefits program.