Quality Assurance Manager

Sotalent; Minnesota; On-site; USD 76,000 - 119,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Parental leave

Mentorship programs

Job summary

Sotalent is seeking an experienced Quality Assurance Manager to oversee quality management, regulatory compliance, and health and safety operations in a pharmaceutical and animal health distribution facility. The role ensures the Quality Management System (QMS) remains effective and GDP compliance across distribution operations.

The position involves collaboration with site leadership, regulatory authorities, and operational teams to maintain compliance, drive process improvements, and foster a

Qualifications

• Bachelor's degree in life sciences, business administration, or related field.
• Minimum 4 years of progressively responsible experience in quality assurance or regulatory compliance.
• Strong knowledge of GDP and pharmaceutical distribution processes.
• Familiarity with FDA, DEA, EPA, OSHA and state regulatory requirements.

Responsibilities

• Manage and maintain the facility's Quality Management System (QMS) and GDP.
• Ensure compliance with FDA, DEA, EPA, OSHA and state regulations.
• Oversee regulatory licensing, registrations, inspections, and compliance documentation.
• Act as the primary contact for regulatory agencies and support inspections.
• Conduct quality, safety, and regulatory assessments.
• Implement CAPA, root cause analysis, and risk management processes.
• Maintain compliance with pharmaceutical storage, transportation, and distribution standards, including USP 1079.

Skills

Quality management

Regulatory compliance

Leadership

Regulatory inspections

Education

Bachelor's degree in Life Sciences, Business Admin., or related field

Job description

Schedule: Monday–Friday, 8:00 AM–4:30 PM, with flexibility required

Salary: $76,200–$119,460 annually (national reference range; location-specific pay may vary)

Industry: Pharmaceutical & Animal Health Distribution

About the Role

An opportunity is available for an experienced Quality Assurance Manager to oversee quality management, regulatory compliance, and health and safety operations within a pharmaceutical and animal health distribution facility.

The position is responsible for maintaining an effective Quality Management System (QMS), ensuring compliance with Good Distribution Practices (GDP), and managing regulatory requirements across distribution operations.

This role involves working closely with site leadership, regulatory authorities, and operational teams to maintain compliance, improve processes, and promote a strong quality and safety culture.

Key Responsibilities

• Manage and maintain the facility's Quality Management System (QMS) and Good Distribution Practices (GDP).
• Ensure compliance with applicable FDA, DEA, EPA, OSHA, and state regulatory requirements.
• Oversee regulatory licensing, registrations, inspections, and compliance documentation.
• Act as the primary point of contact for regulatory agencies and support inspections and investigations.
• Conduct quality, safety, security, and regulatory compliance assessments.
• Implement and monitor corrective and preventive actions (CAPA), root cause investigations, change controls, and risk management processes.
• Maintain compliance with pharmaceutical storage, transportation, and distribution standards, including USP 1079.
• Oversee controlled substance inventory compliance, including DEA Schedule II documentation, inventory reconciliation, and regulatory reporting.
• Ensure compliance with applicable DSCSA, ARCOS, and state reporting requirements.
• Investigate inventory discrepancies, product losses, security incidents, and suspected product integrity issues.
• Monitor temperature controls, security systems, and facility compliance procedures.
• Oversee the facility's Health and Safety Program and associated training.
• Analyse quality metrics, identify trends, and implement continuous improvement initiatives.
• Prepare monthly and quarterly quality performance reports for regional leadership.
• Collaborate with transportation and distribution teams to resolve operational quality issues.
• Promote quality awareness, regulatory compliance, and continuous improvement across the facility.

Required Qualifications & Experience

• Bachelor's degree in Life Sciences, Business Administration, or a related field, or an equivalent combination of education and experience.
• Minimum 4 years of progressively responsible experience in quality assurance, regulatory compliance, pharmaceutical distribution, or a closely related field.
• Strong understanding of Good Distribution Practices (GDP) and pharmaceutical distribution processes.
• Knowledge of federal and state regulatory requirements affecting regulated distribution operations.
• Experience with Quality Management Systems, regulatory inspections, and compliance audits.
• Understanding of CAPA, root cause analysis, risk management, and continuous improvement.
• Strong analytical, organisational, and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to interpret regulatory requirements and implement compliant operational procedures.
• Strong leadership, negotiation, and stakeholder management abilities.
• Advanced proficiency in Microsoft Office applications.

Preferred Skills & Experience

• Experience within pharmaceutical, healthcare, veterinary, or animal health distribution.
• Familiarity with DEA controlled substance regulations, including Schedule II requirements.
• Knowledge of DSCSA, ARCOS, USP 1079, and pharmaceutical storage and transportation standards.
• Experience managing regulatory agency inspections and investigations.
• Continuous improvement experience, including Lean Six Sigma.
• Experience overseeing facility health, safety, and security compliance.
• Annual salary reference range: $76,200–$119,460, subject to location-specific adjustments.
• Medical, dental, and vision benefits.
• Family support and parental leave benefits, subject to eligibility.
• Training, professional development, and mentorship opportunities.

Additional Requirements

• Fully on-site position in Shakopee, Minnesota.
• Standard working hours are Monday–Friday, 8:00 AM–4:30 PM.
• Flexibility to work alternative hours or days depending on operational requirements.