Senior Manager Regulatory Compliance

Medline • Northfield, MN

1d

About The Position

The Senior Manager Regulatory Compliance leads and manages pharmaceutical validation engineering, laboratory quality assurance, and risk management teams to maintain regulatory compliance throughout the organization. The role provides management oversight of validation engineering for drug-product compounding and filling, and for equipment cleaning, applying engineering, chemistry, and microbiological principles. It also oversees the Medline Laboratory Quality Assurance Unit to ensure global compliance with laboratory quality systems and GLP requirements, and integration with risk management programs. The position leads the global Risk Management team, which analyzes quality data and major quality events to monitor and improve risk controls for medical devices, cosmetics, and OTC drugs.

The role manages validation, risk management, and laboratory quality programs and personnel; drives process and system improvements; reviews and approves validation documentation; audits suppliers; supports regulatory inspections and corrective actions; and provides training globally. It also carries management responsibilities that include overseeing major programs and budgets, implementing policies, and hiring, developing, directing, and evaluating staff. Travel of up to 35% is required, including in-state, out-of-state, and international business travel. The position requires willingness to work safely in environments where hazardous chemicals may be encountered.

Requirements

• Bachelor’s degree with a scientific or engineering background.
• At least 5 years of experience in a multidisciplinary role involving medical device and pharmaceutical Quality Management Systems, including validations, risk management, and laboratory systems.
• At least 2 years of experience managing people, 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.
• Willingness to work safely in environments where hazardous chemicals may be encountered.
• Willingness to travel up to 35% for business, including within state, out of state, and 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 experience with Microsoft Word and Excel.

Responsibilities

• Manage development of the validation process program, master validation plan, and strategies supporting pharmaceutical manufacturing.
• Identify, lead, and drive improvements to validation systems.
• Manage personnel overseeing validation of facility utilities, equipment processes, and cleaning for cGMP products, ensuring compliance with applicable regulations.
• Manage supplier master validation plans, including plans for CE-marked devices, and audit suppliers for compliance with Medline validation requirements.
• Review and approve validation protocols and reports.
• Manage development of the global risk management program and strategies, and drive improvements to risk management systems for products and processes.
• Manage global Risk Management personnel overseeing risk management processes for cGMP products and systems, including pharmaceuticals, medical devices, and cosmetics.
• Work with international Risk Management partners to ensure adequate assessments, controls, and continual improvement of the global program as needs and regulations change.
• Align global risk management processes to support consistent risk analysis.
• Manage the Research and Development Laboratories Quality Assurance program, including oversight of laboratory quality systems and GLP compliance.
• Optimize validation, risk management, and laboratory QAU processes to reduce costs and increase capacity.
• Monitor AAMI/ISO standards and assess changes to maintain compliance in validation, laboratory, and risk management practices.
• Review and revise corporate validation, laboratory, and risk management procedures to align with current practices and regulatory requirements.
• Provide global support for FDA and ISO inspections related to validation, risk management, laboratory quality, 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 global personnel on validations, risk management, corrective actions, and quality systems compliance.
• Oversee major projects, programs, and outcomes, and manage budget responsibilities.
• Interpret and execute policies; develop, recommend, and implement new or revised policies.
• Provide staff with general guidelines and parameters for work; hire staff, recommend pay increases, conduct performance reviews, train and develop staff, estimate staffing needs, assign work, and ensure completion dates and consistent policy application.

Benefits

• Competitive total rewards package.
• Continuing education and training.
• Health insurance for eligible employees.
• Life insurance for eligible employees.
• Disability benefits for eligible employees.
• 401(k) contributions.
• Paid time off.
• The role is bonus and/or incentive eligible.
• For employees working less than 30 hours per week on average: access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp.

What This Job Offers

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