Job Details

Quality Assurance Supervisor

At PBI-Gordon Companies, and our subsidiaries PBI-Gordon Corporation, Pegasus Laboratories, and PetAg, Inc, our priority is people, pets, and the places they go. As employee owners, we support each other in building our careers as well as our companies. Our foundation is rooted in integrity, innovation, partnership, and pride. Come grow with us!

Job Summary: The Quality Assurance Supervisor is responsible for overseeing daily QA operations to ensure products and processes comply with current Good Manufacturing Practices (cGMP), FDA, EMA, Health Canada, VICH guidelines, and other regulatory requirements. This role provides leadership to the QA team, supports cross-functional collaboration, and drives continuous quality improvement initiatives within the organization.

Primary Responsibilities/Activities:

• Oversee daily QA operations including raw material/packaging component inspection and release, production floor inspections, label issuance, document control, batch record review and release, deviation management, and change control processes across 2 shifts.
• Ensure compliance with all applicable regulations (GMP, FDA, EMA, Health Canada, VICH) and company quality standards.
• Manage and participate in internal, supplier, customer and regulatory audits; oversee timely resolution of audit findings and implementation of corrective and preventive actions (CAPA).
• Exercise independent judgment to initiate or halt production operations based on quality, safety, and/or regulatory concerns.
• Support and respond to urgent business needs, including corrective actions and critical quality-related decisions.
• Conduct, monitor, and improve training programs to ensure all employees maintain required knowledge and competency levels.
• Supervise, mentor, and manage the workload of QA team members while supporting their professional growth.
• Lead investigations into quality deviations, non-conformances, and customer complaints; ensure thorough root cause analysis and effective CAPA implementation.
• Drive process improvement initiatives to enhance product quality, ensure compliance, and increase operational efficiency.
• Collaborate cross-functionally with Production, QC, Technical Services, and other departments to ensure alignment with quality objectives.
• Collaborate with internal and external stakeholders to identify and resolve quality risks, issues, or concerns.
• Maintain and track quality metrics to monitor trends, identify improvement areas, and report key performance indicators (KPIs) to management.
• Effectively lead and participate in meetings across all organizational levels with strong communication and interpersonal skills.

Qualifications:

• Bachelor's degree in chemistry, biology, or related field
• Minimum 5 years of quality assurance experience in a regulated environment (e.g., pharmaceutical, biotechnology, or medical device), including at least 12 years in a leadership or supervisory capacity.
• Strong understanding of cGMP, FDA, EMA, Health Canada, and other regulatory requirements.
• Proven experience managing audits, CAPAs, document control, and batch record review.
• Strong analytical, problem-solving, and decision-making abilities.
• Excellent written and verbal communication skills.
• Proficiency in quality systems and tools (e.g., QMS, MasterControl, deviation tracking, document management platforms).
• Proficiency in computer systems and tools (e.g., Microsoft office, ERP inventory systems (Microsoft Dynamics 365), labeling software (Loftware).
• Professional certifications (e.g., ASQ, Six Sigma) are a plus.