Hybrid Senior Manager, Quality Assurance

at Inotiv

• Job title: Senior Manager, Quality Assurance
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Alice, United States

About the role

• Senior Manager, Quality Assurance leading quality initiatives and compliance across multiple sites in the drug discovery industry. Ensures regulatory adherence and oversees QA team operations.

Responsibilities

• Leads a Quality Assurance team to ensure compliance with regulatory and statutory requirements, including AAALAC, IACUC, USDA and CDC
• Provides guidance, support, mentoring, and training to direct reports
• Prepares and revises documents that support regulatory and statutory requirements
• Applies rigorous problem-solving methodology to situations where data suggest process is not operating effectively or variability exceeds expectations
• Prepares customer complaint metrics and KPIs, and analyses trends
• Facilitates root cause analysis on significant customer complaints and/or complaint trends
• Assesses nonconformance reports with regards to the level of risk to product quality
• Analyzes trend data to identify key areas of opportunities that impact product quality
• Tracks and trends performance of quality systems and prepares and presents status reports for key performance indicators to management
• Facilitates and reviews customer correspondence associated with complaints
• Reviews and approves complaint investigations and associated RCAs and CAPAs
• Leads and participates in Continuous Improvement projects
• Leads and participates in the Document Control process
• Reviews and approves changes to controlled documentation (policies, procedures, etc.)
• Leads and participates in project teams to implement Quality Management Systems elements including, but not limited to, Deviation Management, Document Control and Change Management related procedures
• Leads and participates in customer, supplier, internal and regulatory audits
• Performs compliance audits against Standard Operating Procedure (SOPs) and Work Instructions (WIs) to determine proper implementation of documents and work practices
• Collaborates cross-functionally to address audit findings by established deadlines
• Conducts training for new hires as required
• Promotes and complies with quality assurance procedures
• Promotes and complies with health and safety procedures
• Six Sigma Green Belt or higher is required
• Regular business travel is required.

Requirements

• 3+ year’s experience in Quality Assurance leadership
• Proficient with advanced skills using Microsoft Excel, Word and PowerPoint
• Experience with laboratory animals, especially rodents preferred
• Working knowledge of business-related processes/procedures terminology and compliance
• Experience using Laboratory Information Management System preferred
• Ability to work either independently or as part of a team
• Demonstrable leadership capabilities with the Ability to develop and foster a positive and productive team environment
• Constructive and approachable
• An individual who possesses initiative, drive, and flexibility with the ability to meet established timelines
• Analytical thinker with the ability to understand problems, determine root cause and recommend appropriate solutions.
• Understand business needs from multiple points of view and provides suggestions to address current issues while also maintaining a long-term solution.
• Excellent verbal and written communication skills; must be able to relate complex concepts in a concise and easy to understand manner with high attention to detail
• Ability to prioritize and handle multiple demands, often under tight time constraints
• An individual capable of operating effectively in a fast paced, dynamic environment
• Adherence to strict quality control and quality assurance principles
• Strong interpersonal/relationship-building skills that establish trust, credibility and respect with a broad range of internal and external stakeholders, including management
• Effectively work with peers, leadership, and stakeholders in a productive collaborative environment.
• Strong commercial skills
• Ability to understand and comply with confidentiality and privacy rules and protect company property and confidential information.
• Empathetic, positive attitude with a desire to help our customers reach their goals

Benefits

• health and dental coverage
• short- and long-term disability
• paid time off
• paid parental leave
• 401K
• and more!