Regional Manager, Quality Management

Cardinal Health•East Hartford, CT

5d•$105,100 - $150,100•Onsite

About The Position

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Management provides strategic oversight, leadership and direction within the Quality function. Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring.

Requirements

Bachelor’s degree in related field, or equivalent work experience, preferred
8-12 years of experience, preferred
2-5 years of experience in the Pharmaceutical Industry preferred
1-3 years of experience in a quality management role preferred
Thorough knowledge of FDA regulatory requirements, controlled environments, good manufacturing practices and quality system requirements
Knowledgeable to validation practices and principles
Excellent interpersonal, organizational and communication skills
Demonstrated leadership and the ability to motivate and influence others
Proficiency with MS Word, PowerPoint and Excel (statistics, graphing, presentations, etc.)
Proactively develops and maintains technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices
Ability to travel to all assigned sites (50%-75%)
Must be located near PET facility or relocation may be required
Manages department operations and supervises professional employees, front line supervisors and/or business support staff
Participates in the development of policies and procedures to achieve specific goals
Ensures employees operate within guidelines
Decisions have a short term impact on work processes, outcomes and customers
Interacts with subordinates, peers, customers, and suppliers at various management levels; may interact with senior management
Interactions normally involve resolution of issues related to operations and/or projects
Gains consensus from various parties involved

Responsibilities

Provides overall direction and management of the QA function that supports their assigned PET manufacturing sites in the United States
Is responsible for all Quality Assurance functions including but not limited to: raw material storage activities, batch record review and approval, product disposition, investigation and remediation of manufacturing issues according to procedure, compliant investigation, execution of validation protocols and site related records management
Provides advice, guidance and training to QA staff in the verification and approval of documents and processes including but not limited to: validation protocols / reports, investigations, procedures and change controls
Providing general oversight to ensure the identity, strength, quality and purity of the drug product released at their sites
Ensuring that all raw materials and finished product meet specifications
Ensuring the review of production records and release of finished product at their assigned sites
Ensuring that all procedures are followed and that all errors and failures to meet specification are appropriately investigated and corrected at their sites
Ensuring regional quality coverage at all assigned sites
Interacts with regulatory agencies, as necessary and ensures the closure any regional FDA commitments on time and its related documentation/objective evidence appropriate
Ensure that the procedures are properly followed and adequate for their intended use
Implements and monitors quality performance measures for the site and reports them to the Director, Quality in a timely manner
Interacts with and provides advice to management and other personnel in the establishment of systems, plans, specifications, methods and procedures
Assess data collected (complaints, investigations, change control, stability failures, etc.) to identify trends and develop corrective actions where needed to ensure compliance with cGMP’s and regulatory requirements
Collaborates with their assigned Area Manager and others to build strategic alliances within the PET network; negotiates to build broad-based support and/or persuades others in order to meet deadlines
Identifies opportunities to improve efficiency while providing flawless transactions, services and products; manages monetary assets and other resources to optimize cost effectiveness
Ensures that customers have a positive experience; commits to meet or exceed customer expectations
Approves change control documents (up to a moderate change)
Initiates investigations and provide direction for corrective action
Determines, develops and delivers training
Develops, reviews and revises quality procedures
Makes hiring decisions for their direct reports
Approves personnel related issues (PTO, travel, etc.)
Deploys employee goals, objectives and performance evaluations
Carries out other duties as described in policies and procedures or as assigned by the Director/Quality