Regional Manager, Quality Management

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
• Ensures that all raw materials and finished product meet specifications
• Ensures the review of production records and release of finished product at their assigned sites
• Ensures that all procedures are followed and that all errors and failures to meet specification are appropriately investigated and corrected at their sites
• Ensures 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
• 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
• Affirms 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

Qualifications

• 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