Manager – Quality Management

Manager – Quality Management

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

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.
• The Regional Quality Manager (RQM) has the authority to: 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.

Preferred 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