QA Manager

PerrigoAllegan Township, MI
Onsite

About The Position

At Perrigo, we are dedicated to making lives better by delivering high-quality, affordable self-care products that consumers trust worldwide. As the Quality Assurance Manager, you will play a critical leadership role in ensuring the safety, quality, and compliance of our products throughout manufacturing, packaging, and product release operations. This position provides quality oversight for site operations, driving a culture of quality, regulatory compliance, continuous improvement, and operational excellence. The Quality Assurance Manager partners cross-functionally with Operations, Engineering, Maintenance, Laboratory, and Quality teams to identify risks, resolve quality issues, and implement sustainable improvements that enhance product and process performance. The successful candidate will lead and develop quality professionals, support regulatory and customer audits, provide risk-based decision making, and ensure compliance with cGMP requirements, FDA regulations, and company standards. This role is ideal for a collaborative leader who is passionate about building high-performing teams while advancing quality systems that protect consumers and support business success.

Requirements

  • 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
  • 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

Responsibilities

  • Manages support for contract or retail customer technical questions, and/or to provide technical impact or risk assessment
  • 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
  • Partners with Site Quality Leadership to align processes with PMI and OTC objectives
  • 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

  • Competitive compensation
  • Benefits tailored to supporting you and your family
  • Career development opportunities
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