Senior Manager Regulatory Compliance

Medline Industries, LP; Mundelein (IL); On-site; USD 154,000 - 231,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a senior leader to drive pharmaceutical validation engineering, laboratory quality assurance, and risk management across the organization. You will oversee validation programs, GLP compliance, and global risk controls for pharmaceuticals, medical devices, and cosmetics.

The role requires expertise in cGMP, FDA/ISO standards, and global regulatory alignment, with travel up to 35%. A strong leadership background and relevant scientific/engineering degree are essential.

Qualifications

• Bachelor’s degree with a scientific or engineering background.
• At least 5 years of experience in 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.
• Experience applying knowledge of process validation, method validation and GLP requirements.
• Experience with FDA inspections and FDA 483 response writing.
• Experience with Risk Management global expectations.

Responsibilities

• Lead validation process program development and strategies to support manufacturing of pharmaceutical products.
• Audit and oversee validation of facility utilities, equipment processes and cleaning for cGMP products to adhere to regulatory requirements.
• Manage supplier master validation plans and audit suppliers for compliance.
• Develop global risk management program and drive improvements across products and processes.
• Oversee global Risk Management personnel for cGMP products and systems compliance.
• Collaborate with international risk management partners to align processes and meet global regulations.
• Provide training to personnel globally on validations, risk management, corrective actions, and quality systems compliance.

Skills

Regulatory compliance knowledge

Leadership

Analytical skills

Communication

Microsoft Word

Microsoft Excel

Education

Bachelor’s degree in engineering, chemistry or biological sciences

Tools

Microsoft Word

Microsoft Excel

Job description

Job Summary

Responsible for leading and managing pharmaceutical validation engineering, laboratory quality assurance, and risk management teams to assure regulatory compliance throughout the organization.
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.
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.
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.
• Experience applying knowledge of process validation, method validation and GLP requirements.
• Experience with FDA inspections and FDA 483 response writing.
• Experience with Risk Management global expectations.

Knowledge / Skills / Abilities:

• Must be willing to work safely in environments where hazardous chemicals may be encountered.
• Position requires travel up to 35% of the time for business purposes (within state, out of state and/or internationally).

PREFERRED JOB REQUIREMENTS:

Education:

• Bachelor’s degree in engineering, chemistry or biological sciences.

Certification / Licensure:

• None

Work Experience:

• Experience auditing compliance to FDA regulated Medical Device or Pharmaceuticals requirements.
• Experience with regulated Medical Device or Pharmaceutical risk management practices.

Knowledge / Skills / Abilities:

• Advanced Microsoft Word and Excel experience

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$154,000.00 - $231,000.00 Annual

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

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, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here https://urldefense.com/v3/ https:/digital.alight.com/medline ;!!DjNdo6avjEs!o-bxZ6fy_WNH13q2FLYYmUMb1U4cic3ioox3ulm5dkpyivWM09cd64RN8rHuDH5AQKNiwEzHU2VbVJht5ginULSy5aJGsA$.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.