Manager of Regulatory Compliance

Medline Industries, LP

2d • $134,000 - $201,000

About The Position

JOB SUMMARY Responsible for leading the management of master validation program and compliance maintenance to assure global regulatory validations requirements in Medline manufacturing facilities, contract manufactured products, and software systems. Support Corporate Process Validation program and related activities, analyzes problems related to quality manufacturing, risk management, global regulatory information, and to provide systems and technical support resolution MAJOR RESPONSIBILITIES Support senior management in development of validations process, master validation plan, and strategies that support the success of the business. Identifies, leads, and drives opportunities to improve validation systems. Manage the Compliance Master Validations team responsible for oversight of the validation of software, 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. Develop and Manage Medline’s supplier master validation plans and validation documentation meets all applicable requirements, including those for CE marked devices for process, cleaning, and software validations. Audit Suppliers to assure compliance to Medline’s validation requirements. Lead validation process and optimize the current processes to reduce costs and increase capacity. Review and approve Medline validation protocols and reports. Stay current with AAMI/ISO standards and review changes to make sure validations are in compliance with new domestic and global requirements. Review and revise Corporate Validation procedures and processes to make sure they are in line with current practices and regulatory requirements. Execute responsibilities as CRB team member to assure adequacy of corrective actions including identify risk and compliance opportunities. Assist in Risk Management activities including those related to validations and CRB activities. Provide global support for FDA and ISO inspections related to validations and validation strategy. Provide training to personnel globally on a variety of topics related to validations and process controls. Management responsibilities include: Typically oversees professional employees/teams OR typically manages non-professional employees through Supervisors in manufacturing, distribution or office environments. Day-to-day operations of a group of employees. May have limited budgetary responsibility and usually contributes to budgetary impact; - Interpret and execute policies for departments/projects and develops. 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.

Requirements

• Bachelor’s degree in engineering, chemistry, biology, or related sciences.
• At least 4 years of experience with medical device or pharma, QA and/or Quality Management Systems including validations.
• Experience authorizing medical device process validation protocols and reports
• Detail-oriented with excellent oral and written communication skills.
• Ability to listen and process all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions.
• Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary.
• Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines.
• Position requires travel up to 20% of the time for business purposes (within state, out of state and/or internationally).

Nice To Haves

• At least 5 years of experience with medical device or pharma, QA and/or Quality Management Systems including validations.
• At least 1 year of experiencing with managing people within an FDA regulated environment.
• Experience developing validation strategies and programs.
• Experience auditing compliance to FDA regulated Medical Device or Pharmaceuticals requirements.
• Experience with regulated Medical Device or Pharmaceutical risk management practices.

Responsibilities

• Support senior management in development of validations process, master validation plan, and strategies that support the success of the business.
• Identifies, leads, and drives opportunities to improve validation systems.
• Manage the Compliance Master Validations team responsible for oversight of the validation of software, 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.
• Develop and Manage Medline’s supplier master validation plans and validation documentation meets all applicable requirements, including those for CE marked devices for process, cleaning, and software validations.
• Audit Suppliers to assure compliance to Medline’s validation requirements.
• Lead validation process and optimize the current processes to reduce costs and increase capacity.
• Review and approve Medline validation protocols and reports.
• Stay current with AAMI/ISO standards and review changes to make sure validations are in compliance with new domestic and global requirements.
• Review and revise Corporate Validation procedures and processes to make sure they are in line with current practices and regulatory requirements.
• Execute responsibilities as CRB team member to assure adequacy of corrective actions including identify risk and compliance opportunities.
• Assist in Risk Management activities including those related to validations and CRB activities.
• Provide global support for FDA and ISO inspections related to validations and validation strategy.
• Provide training to personnel globally on a variety of topics related to validations and process controls.
• Management responsibilities include: Typically oversees professional employees/teams OR typically manages non-professional employees through Supervisors in manufacturing, distribution or office environments. Day-to-day operations of a group of employees. May have limited budgetary responsibility and usually contributes to budgetary impact; - Interpret and execute policies for departments/projects and develops. 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.

Benefits

• Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
• Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
• For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees