Director, Process Control and Data Analytics

Job Description

The Director of Process Control and Data Analytics will be responsible for leading a team focused on developing and implementing product control strategies, statistical analysis, and advanced statistical methods for medical device and combination product engineering within the pharmaceutical company. The position requires a strong understanding of statistical principles, expertise in medical devices and combination product processes, and analytical testing for devices, as well as the ability to enhance the organization's big data skill set and connect with digital efforts. The ideal candidate will have a background in data science, statistics, and a strong understanding of medical device and combination product regulations and processes.  It is expected that this role will lead significant investigations or events directly, and mentor and coach their team to provide on-going support.

Essential Duties and Responsibilities:

• Lead and manage a team of subject matter experts focusing on product control strategies, statistical analysis, and advanced statistical methods, including principal component analysis, etc.
• Develop and implement statistical process control methodologies and data anlaysis to ensure the quality and reliability of autoinjector and syringe products, and other medical device and combination products.  Ensure these efforts are integrated with the product stewardship organization.
• Through team members analyze and issue routine data reports and analysis, such as product complaints and on-going performance data, to drive deeper technical understanding and proactive problem identification and resolution.  
• Through team members, rapidly and thoroughly map process control strategies across processes end to end, analyzing tests methods and controls, to generate a comprehensive assessment of product performance.  Identify critical attributes, and create and implement prospective monitoring plans
• Ensure data analysis using structured and modern data science techniques, and provide mentorship and training to build the team's capabilities.
• Ensure seamless interface in the Device Development and Technology team including process stewardship and technical transfer functions.  Act as a liaison between the device process teams and partner groups including the statistical centers of excellence, quality, sites, and digital and other departments.

Qualifications:

• Master's or Ph.D. in Statistics, Data Science, Engineering, or related field.
• Minimum of 8 years of experience in statistical analysis and statistical process control within the medical device or pharmaceutical industry.
• In-depth knowledge of medical device and combination product regulations, manufacturing processes, and quality control.
• Proficiency in advanced statistical methods, such as partial least squares regression, multivariate analysis, and design of experiments.
• Demonstrated leadership and management experience, including the ability to build and develop high-performing teams.
• Strong communication and interpersonal skills, with the ability to collaborate with cross-functional stakeholders and interface with other departments.

Preferred Qualifications:

• Experience in leveraging big data and digital technologies for statistical analysis and product control strategies.
• Background in data science and machine learning techniques for analyzing complex datasets.
• Knowledge of Six Sigma methodologies and structured problem-solving approaches.
• Experience with technical transfer and lifecycle support for medical devices and combination products.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirement