Manager, Quality & Regulation in Libertyville, IL at Johnson Service Group

Date Posted: 9/14/2021

Job Snapshot

Job Description

JobID: 386271

Johnson Service Group (JSG) is a nationally recognized Contract Engineering and Technical Staffing firm specializing in Engineering and Manufacturing. We are currently recruiting for a Manager of Quality and Regulatory

POSITION SUMMARY
Responsible for the overall quality and regulatory leadership for reverse distribution activities related to receipt, storage, handling, and destruction of regulated healthcare products.  Leads the company as the quality and regulatory director to ensure a company-wide culture compliant with applicable DEA, FDA, and EPA as well as other relevant regulations.  Interfaces with the executive management team to establish and maintain all aspects of the quality system and communicates quality and regulatory risks.  Leads company during customer and agency inspections.  Provides recommendations and solutions to quality and regulatory challenges.

KEY SKILLS & COMPETENCIES

General Skills

Developing Oneself                      Teamwork                        Flexibility                          Drive for Results

Leadership                                     Planning                            Problem Solving              Communication                            

Initiative                                         

ESSENTIAL FUNCTIONS

Responsibility

% Time

Regulatory Compliance

  • Lead all regulatory agency inspections providing timely updates to senior management and key stakeholders.
  • Responsible for all aspects of controlled substance security, training, access authorization and power of attorney issuance and revocation.
  • Execute and/or direct all facility licenses, registrations, certifications (State Board of Pharmacy, DEA, EPA, VAWD)
  • Ensure compliance with regulatory reporting requirements e.g. DEA Form-222, DEA Form-41, DEA Form-106, and EPA Large Quantity Generator reports.
  • Monitor proposed or emerging DEA, EPA, FDA regulations, assess potential impact, and coordinate any change management activities to ensure compliance.
  • Thorough knowledge and understanding of DEA, GMP, GDP and ARCOS reporting.

40%

Quality Systems Management

  • Responsible for oversight and/or administering all aspects of the Quality Management System.
  • Lead/perform internal audits to ensure compliance with internal procedures as well as state and federal regulatory requirements.
  • Review and prepare non-conformances, corrective actions, observations, and provide recommendations for changes and/or processes.
  • Responsible for developing and implementing Quality System Procedures and company work instructions.
  • Actively manage, support and participate in Quality Management System training programs and other quality related training.

35%

Customer Management

  • Review, revise, approve and execute Quality Agreements with healthcare manufacturers.
  • Manage all current client and prospective client inspections.

10%

Supplier Management

  • Direct the assessment, approval and monitoring of all company suppliers and service providers.

10%

Additional Responsibilities

  • Identifies and manages continuous improvement projects that may span multiple departments with the objective of achieving quality and cost improvements.
  • Drive continual process improvements based on appropriate metrics and key performance indicators (KPIs).
  • Assistance with waste classification process.

5%

KNOWLEDGE AND SKILLS

  • Knowledge of and compliance to FDA, DEA, cGMP, NABP requirements.
  • Strong drive for continuous improvement
  • Strong organizational, communication, and people skills.
  • Ability to travel.
  • People management or supervisory experience.
  • Good knowledge of the company’s service offering.

QUALIFICATIONS: The individual in this position must be authorized to work in the U.S.  And will need to consent to a criminal background check, and a drug test. 

REQUIREMENTS  

  • Bachelor’s Degree or equivalent experience in regulated industry e.g. medical products, nutritionals.
  • 10+ years’ experience working in quality, warehouse/distribution or related field in the medical or pharmaceutical industry. 

WORKING CONDITIONS: This position requires working in a professional office environment along with the ability to give detailed tours of the warehouse facility.

#D100




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