Director of Quality Assurance

2 days ago

Middleton, Wisconsin, United States LGC Biosearch Technologies Full time
Job Title: Director of Quality Assurance, Reagents & Instrumentation

At LGC Biosearch Technologies, we are seeking a highly skilled and experienced Director of Quality Assurance, Reagents & Instrumentation to lead our quality assurance team across multiple operational sites. As a key member of our organization, you will be responsible for ensuring the effective implementation of quality assurance processes, compliance with regulatory standards, and the delivery of high-quality products to our customers.

Key Responsibilities:
  • Lead a team of quality assurance professionals to deliver on operational activities, ensuring compliance with quality, safety, and regulatory standards.
  • Responsible for personnel activities, including budgeting, staffing, training, performance evaluations, mentoring, and coaching.
  • Serve as the principal QA business partner to business and senior management, providing guidance on operational quality assurance, compliance, and risk management.
  • Partner with functional stakeholders to lead and implement transformational efforts for improving product quality and driving a culture that values compliance, customer satisfaction, safety, quality, teamwork, and goal achievement.
  • Oversee the performance of internal and external audits at operational sites.
  • Ensure the effective creation, review, and maintenance of QA policies, procedures, and processes.
  • Develop and maintain mutually beneficial partnerships with other functional leaders.
Requirements:
  • Bachelor's degree required, graduate degree preferred.
  • Prior working experience in an in vitro diagnostics, biotechnology, or biopharma organization is strongly preferred.
  • Prior working experience in a GMP-certified manufacturing environment is preferred.
  • Proven expertise with a cloud-based quality management system, ideally ETQ Reliance is preferred.
  • Experience managing the QA function and delivery of associated operational processes at an operational site or multiple sites with revenues of $50 million or more within an ISO-certified manufacturing environment.
  • Experience managing and developing business staff, with the demonstrated ability to effectively lead and manage a team in a dynamic working environment.
  • Experience directing and chairing large-group engagements, such as customer or supplier audits, ISO (re)certifications, and company management reviews.
  • Demonstrated experience leading cross-functional risk analyses and root cause investigations throughout the product manufacturing lifecycle.
What We Offer:
  • Competitive compensation with strong bonus program.
  • Comprehensive medical, dental, and vision benefits for employees and dependents.
  • FSA/HSA Pre-tax savings plans for health care, childcare, and elder care.
  • Deductible Buffer Insurance and Critical Illness Insurance.
  • 401(k) retirement plan with matching employer contribution.
  • Company-paid short- and long-term disability, life insurance, and employee assistance program.
  • Flexible work options.
  • Pet Insurance for our furry friends.
  • Enhanced Parental leave of 8 additional weeks.
  • PTO that begins immediately.
  • Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Company wide social events, frequent catered lunches and much more.

LGC Biosearch Technologies is an equal opportunities employer and welcomes applications from all qualified candidates. All information will be kept confidential according to EEO guidelines.

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