Senior Manager Regulatory Compliance

Medline Industries, LP • Mundelein, IL

2d • $154,000 - $231,000

About The Position

The Senior Manager Regulatory Compliance leads and manages pharmaceutical validation engineering, laboratory quality assurance, and risk management teams to assure regulatory compliance throughout the organization. The role provides management oversight of validation engineering for the compounding, filling, and cleaning of drug products and equipment, applying engineering, chemistry, and microbiological principles. It also oversees the Laboratory Quality Assurance Unit to ensure global compliance with Laboratory Quality Systems and GLP requirements, and manages the Risk Management team’s global work to monitor and improve controls for medical devices, cosmetics, and OTC drugs.

The position manages the development and improvement of validation and risk management programs, master plans, and strategies; oversees supplier validation plans and audits; and leads the laboratory quality assurance program for Research and Development laboratories. It works with international partners to align risk-management processes and support changing global requirements. The role also supports FDA and ISO inspections, corrective actions, out-of-specification investigations, staff training, and continuous improvement of validation, laboratory, and risk management processes.

This management position typically leads through multiple managers and/or supervisors, oversees major projects and programs, has budget responsibility, and handles staffing and personnel development responsibilities. Travel may be required up to 35% for business purposes, including within state, out of state, and internationally.

Requirements

• Bachelor’s degree with a scientific or engineering background.
• At least 5 years of experience in a multidisciplinary medical device and pharmaceutical Quality Management Systems role, including validations, risk management, and laboratory systems.
• At least 2 years of people-management experience, including hiring, developing, motivating, and directing employees.
• Experience with FDA regulations, including 21 CFR 820 and 21 CFR 210/211.
• Experience with ISO 13485 and ISO 17025.
• Experience with MDSAP and MDD/MDR regulations.
• Experience applying knowledge of process validation, method validation, and GLP requirements.
• Experience with FDA inspections and writing FDA 483 responses.
• Experience with global Risk Management expectations.
• Must be willing to work safely in environments where hazardous chemicals may be encountered.
• Willingness to travel up to 35% for business, within state, out of state, and/or internationally.

Nice To Haves

• Bachelor’s degree in engineering, chemistry, or biological sciences.
• Experience auditing compliance with FDA-regulated medical device or pharmaceutical requirements.
• Experience with regulated medical device or pharmaceutical risk management practices.
• Advanced Microsoft Word and Excel experience.

Responsibilities

• Manage development of the validation process program, master validation plan, and strategies supporting pharmaceutical product manufacturing, and drive improvements to validation systems.
• Manage personnel overseeing validation of facility utilities, equipment processes, and cleaning for cGMP products, including pharmaceuticals, medical devices, and cosmetics.
• Manage supplier master validation plans, audit suppliers for compliance with Medline’s validation requirements, and review and approve validation protocols and reports.
• Manage the development of the global risk management program and strategies, identifying and driving improvements to risk management systems for products and processes.
• Manage global Risk Management personnel responsible for developing and controlling risk management processes for cGMP products and systems.
• Work with international Risk Management partners to ensure risk assessments, controls, and continuous improvement meet global needs and changing regulations, and align risk analysis processes consistently.
• Manage the Research and Development Laboratories Quality Assurance program, including oversight of laboratory quality systems and GLP compliance.
• Lead validation, risk management, and laboratory QAU process optimization to reduce costs and increase capacity.
• Monitor AAMI/ISO standards and regulatory changes; review and revise Corporate Validation, Laboratory, and Risk Management procedures to keep them aligned with current practices and requirements.
• Provide global support for FDA and ISO inspections related to validation, risk management, laboratory matters, and corrective actions.
• Serve as a CRB team member to assess corrective-action adequacy and identify risk and compliance opportunities.
• Serve as a QAU team member to assess OOS investigations, identify root causes, and identify corrective-action opportunities.
• Train personnel globally on validation, risk management, corrective actions, and quality systems compliance.
• Oversee major projects and programs, manage budgets, interpret and implement policies, and recommend or implement policy changes.
• Lead staff activities including hiring, recommending pay increases, performance reviews, training and development, estimating staffing needs, assigning work, and ensuring timely completion and consistent application of organizational policies.

Benefits

• Competitive total rewards package.
• Continuing education and training.
• Health insurance, life and disability insurance, 401(k) contributions, and paid time off for employees working an average of 30 or more hours per week.
• For employees working fewer than 30 hours per week: 401(k) contributions, paid time off, access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp.
• Bonus and/or incentive eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior