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Manager of Quality Systems

2 months ago

Eagan, Minnesota, United States Bell International Laboratories Full time
Job Overview

As the Manager of Quality Systems, you will spearhead and oversee the Quality Systems division, collaborating closely with the Vice President of Quality and Regulatory Compliance on all matters related to quality, regulatory standards, and compliance. This position is crucial in maintaining cGMP compliance during audits conducted by regulatory bodies and clients. You will ensure that all operations conform to regulatory and cGMP standards as well as the policies and procedures of Bell International Laboratories.

Key Responsibilities

  • Supervise the Change Control process and provide Quality Guidance across the organization.
  • Lead the creation of Standard Operating Procedures (SOPs), manage the review and approval processes for Deviations and Corrective and Preventive Actions (CAPA), and offer guidance. Oversee the entire Deviation and CAPA programs.
  • Manage the daily functions of the Quality Control Technicians.
  • Take responsibility for the training and development of team members, fostering motivation among supervised staff.
  • Oversee the Recall and Mock Recall processes.
  • Facilitate Quality Management Review Meetings and track Action Items.
  • Contribute to the formulation and justification of the annual Quality Assurance budget. Engage in planning and forecasting, providing analysis and monitoring to support Bell International Laboratories.
  • Manage, track, and ensure compliance with annual budget requirements.
  • Review and approve timecards and PTO requests for direct reports.
  • Perform additional duties and assignments as required.

Essential Skills and Qualifications

  • Bachelor's degree required, preferably in Life Sciences, Chemistry, Medical Technology, or equivalent experience in the pharmaceutical sector.
  • Minimum of 5 years of experience in Quality Systems within the Pharmaceutical or Medical Device industries.
  • Strong understanding of cGMP compliance and the ability to effectively communicate with regulatory agencies and clients.
  • In-depth knowledge of Risk Assessment related to recalls, deviations, and non-compliance incidents.
  • Comprehensive understanding of pharmaceutical manufacturing and packaging processes.
  • Exceptional leadership and coaching abilities.
  • Demonstrated ability to collaborate effectively with other departments.
  • Proven history of maintaining regulatory compliance.
  • Excellent writing and interpersonal skills are essential.
  • Proficient in Microsoft Office Suite (Word, PowerPoint, and Excel).

Equal Employment Opportunity Statement

Bell International Laboratories is committed to providing equal employment opportunities to all employees and applicants, prohibiting discrimination and harassment of any kind based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all aspects of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.