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Inotiv · 1 day ago

Regional Manager, Quality Assurance

Alice, TX

Full-time

Onsite

Mid, Senior Level

3+ years exp

Inotiv is a growing contemporary drug discovery and development company, and they are seeking a Regional Manager, Quality Assurance. The manager will oversee quality assurance processes and ensure compliance with regulatory requirements while leading a team to support quality management systems across multiple sites.

BiopharmaLife ScienceMedical DevicePharmaceutical

Hiring Manager

Julie Melton, EdD

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

Performs other duties as assigned

Qualification

Quality Assurance leadershipRoot Cause Analysis (RCA)CorrectivePreventive Action (CAPA)Quality Management SystemsSix Sigma Green BeltLaboratory Information Management SystemMicrosoft ExcelMicrosoft WordMicrosoft PowerPointAnalytical thinkingLeadership capabilitiesInterpersonal skillsCommunication skillsTeam collaboration

Required

3+ year's experience in Quality Assurance leadership

Proficient with advanced skills using Microsoft Excel, Word and PowerPoint

Working knowledge of business-related processes/procedures terminology and compliance

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

Regular business travel is required