POSITION OVERVIEW: The Sr. Operations Manager is responsible to perform duties including, operational support, quality monitoring, problem solving, process improvement, CAPA management and internal/external auditing. Knowledge of commonly used concepts practices and procedures within the field are required. The position relies on training, experience, and judgment to plan and accomplish goals. A certain degree of creativity and latitude is required while performing a variety of complex tasks. This position will be responsible for managing the timely and cost-efficient global movement of goods. The position will have responsibility for the operations and quality of logistics and distribution services of high value products.

JOB RESPONSIBILITIES:

• Develop, maintain, and improve temperature-controlled transportation processes across multiple functions and / or business units. Provide leadership, experience, and knowledge to diverse team consisting of middle and senior management. Technical expertise and management in implementing projects supporting Supply Chain operations globally.
• Provide leadership in project and change management while leading continuous improvement efforts that impact Packaging Engineering and Logistics / Transportation Operations. Serves as subject matter expert for Good Distribution Practice (GDP) compliance across a global footprint.
• Apply expert knowledge of Good Distribution Practice in delivering logistics process oversight in the development, clinical, and commercial supply chains. Perform oversight of 3PL companies and specialty distributors quality management systems; facilities, equipment, vehicles; logistics processes and documentation.
• Maintain and manage risk-based model for management of GDP activities

• Drive the identification, implementation, and use of statistical methods throughout the plant. Statistical methods include Statistical Process Control (SPC), Designed Experimentation (DoE), and acceptance sampling among others. Establish, monitor, analyze, and report on the major quality indicators for the plant. Utilize accepted capability indicators (CP, CpK, PPM, etc.). Create and facilitate problem-solving teams, including the use of problem-solving tools such as FMEA.

• Investigate, analyze, develop, and determine processes and process improvements on existing products to improve quality and or productivity. Develop and implement quality tools in the line such as defect tracking, random audits, verification check sheets, etc.
• Assist establishing, implementing, and maintaining the quality management system. Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.
• Plan and implement projects to improve quality control and monitor internal quality. Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions. Analyze failure, corrective, and preventive action to respond to customer complaints.
• Interface with external customers and suppliers on quality-related issues. Create and maintain company quality documentation, such as quality manuals, quality procedures, etc. Continuously improving QA receiving inspection process and procedures.
• Ensure timely resolution of supplier failure, corrective actions, and preventive actions. Manage suppliers’ performance and conduct audits.
• Ability to establish scalable processes for inventory control and distribution across multiple locations.
• Perform duties in accordance with established quality standards. Actively support Health, Safety and Environment rules and regulations. All other duties and responsibilities as assigned.

ABILITIES REQUIRED:

• Good understanding of GDP Regulations
• Significant and demonstrable experience of working in a similar compliance related role within the pharmaceutical industry
• Packaging Engineering degree or experience ideal
• Strong interpersonal / communication skills are required to engage cross functionally at all levels of the organization
• Expertise operating in a regulated environment and the transportation industry globally
• Subject matter expert in thermal packaging within Biotech / Pharmaceutical industry, ideal
• Track record of increasing responsibilities serving as a change agent leader
• Travel estimated up to 20%.

QUALIFICATIONS:

• Bachelor’s degree (preferred) or higher in scientific, medical or logistics related discipline.
• Minimum of 5 years of experience in a cold chain logistics role in the pharmaceutical, biotech or related industry.
• Minimum of 3 years of experience in an GMP environment
• Project Management Certification preferred