Regional Manager, Quality Assurance

Inotiv•Alice, TX

27d•Onsite

About The Position

The Regional Manager, Quality Assurance is responsible for performing responsibilities as assigned to effectively support implementation of the Quality Management System at the two Alice, TX sites and the one Denver, PA site. The manager will provide quality oversight for customer complaint management, root cause analysis (RCA), corrective and preventive action (CAPA) management, and documentation. The manager will oversee processes, such as the external and internal audit program, deviation management, change control, electronic quality management systems, quality training, and data collection. The manager is required to support nonhuman primate operations in achieving compliance to quality and animal welfare requirements, company policies and procedures, as well as all applicable regulatory requirements. The Regional Manager is expected to work on site daily at the Alice, TX sites and travel to Denver, PA every four to six weeks.

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

Nice To Haves

Six Sigma Green Belt is preferred

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
Regular business travel is required
Performs other duties as assigned