Senior Manager Regulatory Compliance

Job Summary

Responsible for leading and managing pharmaceutical validation engineering, laboratory quality assurance, and risk management teams to assure regulatory compliance throughout the organization.<br>Provide management oversight of pharmaceutical validation engineering for the compounding, filling and cleaning of drug products and equipment using engineering, chemistry and microbiological principles to meet regulatory requirements.<br>Provide management oversight of the Medline Laboratory Quality Assurance Unit to assure global regulatory compliance with Laboratory Quality Systems, GLP requirements and integration into risk management programs.<br>Provide management oversight of the Risk Management team, which monitors, maintains, and enhances risk controls by analyzing quality data and major quality events to ensure Medline is properly controlling risks on a global level for medical devices, cosmetics, and OTC drugs.

Job Description

MAJOR RESPONSIBILITIES:

• Manage Medline’s development of the validation process program, master validation plan, and strategies that support the manufacturing of pharmaceutical products. Identifies, leads, and drives opportunities to improve validation systems.
• Manage the Compliance Master Validations personnel responsible for oversight of the validation of facility utilities, equipment processes and cleaning for cGMP products such as pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820, and other applicable regulatory requirements.
• Manage Medline’s supplier master validation plans including those for CE marked devices. Audit Suppliers to assure compliance to Medline’s validation requirements. Review and approve validation protocols and reports.
• Manage Medline’s development of global risk management program and strategies that support the success of the business. Identifies, leads, and drives opportunities to improve risk management systems pertaining to products and processes.
• Manage Medline’s global Risk Management personnel responsible for oversight of the development and control of risk management processes for cGMP products/systems such as pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820, and other applicable regulatory requirements.
• Work with international Risk Management partners to ensure adequate assessment, controls, and continuous improvement of Medline’s Risk Management program to meet global needs and changing regulations. Align global risk management processes to ensure that risks are being analyzed consistently.
• Manage Medline’s Research and Development Laboratories Quality Assurance program responsible for oversight of the of the laboratories quality systems and GLP compliance
• Lead validation, risk management, and laboratory QUA optimization of the current processes to reduce costs and increase capacity.
• Stay current with AAMI/ISO standards and review changes to make sure validations, laboratory, risk management practices an are in compliance with new requirements. Review and revise Corporate Validation, Laboratory, and Risk Management procedures to make sure they are in line with current practices and regulatory requirements.
• Provide global support for FDA and ISO inspections related to validation, risk management, laboratory and corrective actions.
• Execute responsibilities as CRB team member to assure adequacy of corrective actions including identify risk and compliance opportunities. Execute responsibilities as QAU team member to assure adequacy OOS Investigations including identify root cause and corrective action opportunities.
• Provide training to personnel globally on a variety of topics related to validations, risk management, corrective actions, and quality systems compliance.
• Management responsibilities:

• --Typically manages through multiple Managers and/or Supervisors
• --Oversee major projects/programs/outcomes
• --Budget responsibility
• --Interpret and execute policies for departments/projects; develop, recommend and implement new policies or modifications to existing policies
• -Provide general guidelines and parameters for staff functioning
• --Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies

MINIMUM JOB REQUIREMENTS:

Education:

• Bachelor’s degree with a scientific or engineering background.

Certification / Licensure:

• n/a

Work Experience:

• At least 5 years of experience within a multi discipline role in medical device and pharma Quality Management Systems including validations, risk management, laboratory systems.
• At least 2 years of experience managing people; including hiring, developing, motivating and directing people as they work.
• Experience with FDA regulations (21 CFR 820, 21 CFR 210/211).
• Experience with ISO 13485 & 17025.
• Experience with MDSAP and MDD/MDR regulations.

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