QA Manager

PerrigoAllegan Township, MI

About The Position

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it. Overview: Ensures that company products meet defined quality standards through Quality management and oversight of the manufacturing, packaging, and QA release teams.Scope of the Role

Requirements

  • Strong problem-solving skills, and logical approach based on sound judgment and research
  • Sound understanding of cGMP/FDA regulations: CFR and FDA guidance documents related to drug manufacturing (21 CFR 210/211).
  • Subject matter expertise that extends beyond the area of responsibility
  • Typically a minimum of 8 years in the field and 4 years supervisory experience. University Degree or equivalent
  • Bachelor's degree within related discipline required
  • Six or more years’ experience in a regulated industry, pharma preferred
  • Demonstrated ability in areas of people leadership and quality leadership
  • Excellent written and oral communication skills

Responsibilities

  • Manages support for contract or retail customer technical questions, and or to provide technical impact or risk assessments
  • Promotes development and succession planning for direct and indirect reports within area of responsibility
  • Manages and leads cross functional continuous improvement opportunities and projects
  • Develops and maintains auditing and release procedures which ensure products released for shipment meet company, customer and FDA standards
  • Provides risk assessment over significant Quality events
  • Works with operations, laboratory, engineering, and maintenance managers and staff to develop, evaluate and implement action plans which maintain or improve product and process quality
  • Reviews and approves Standard Operating Procedure updates, change control, and validation reports.
  • Leads and guides others in quality driven initiatives in the continuous support of Quality Improvement
  • Final quality approver for standard work instruction (SWI) and standard operating procedures (SOP)
  • Supports FDA, customer, internal, and other regulatory audits and responses

Benefits

  • We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.
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