Head of Quality Assurance Operations

1 week ago

Middleton, Wisconsin, United States LGC Biosearch Technologies Full time
Job Overview

Company Overview:
LGC Biosearch Technologies is a prominent global provider of life science tools, delivering essential components and solutions across high-growth sectors in human healthcare and applied markets. Our extensive product range includes critical tools for genomic analysis and quality assurance applications, integral to our customers' workflows and recognized for their superior performance and quality.

Our products are vital in various customer workflows, facilitating the introduction of new diagnostics and therapies, advancing research and development, optimizing food production, and ensuring the continuous monitoring and enhancement of quality in food, environmental, and consumer products.

With over 175 years of scientific expertise, LGC has established a robust product portfolio and developed strong relationships with customers, industry partners, and the global scientific community. Join us in our mission of Science for a Safer World.

Position Summary:
Located at our operational site, the Director of Quality Assurance for Reagents & Instrumentation will spearhead a team of Quality Assurance professionals across multiple operational sites dedicated to product manufacturing and delivery. This role is pivotal as the primary QA business partner for the product portfolio, overseeing a team across various locations to ensure effective management of personnel, alignment of QA priorities, and achievement of functional objectives in support of broader business operations.

Travel & Time Expectations: This role may require travel up to 30% of the time and may involve evening or weekend hours to meet business and customer needs.

Key Responsibilities:
  • Lead the QA team across operational sites to ensure compliance with quality, safety, and regulatory standards.
  • Manage personnel activities including budgeting, staffing, training, performance evaluations, mentoring, and goal setting.
  • Act as the principal QA business partner to senior management, providing insights on operational quality assurance, compliance, and risk management.
  • Collaborate with functional stakeholders to implement initiatives that enhance product quality and foster a culture of compliance and customer satisfaction.
  • Oversee internal and external audits at operational sites.
  • Ensure the development and maintenance of QA policies and procedures related to product design verification, validation, and documentation control.
  • Engage in talent development to achieve organizational objectives within the QA function.
  • Lead local and global projects beyond daily operational responsibilities.
  • Establish partnerships with other functional leaders across the organization.
  • Adhere to the site's quality management system requirements.
  • Perform additional duties as assigned to meet business needs.
Qualifications:
  • Bachelor's degree required; Graduate degree preferred.
  • Experience in in vitro diagnostics, biotechnology, or biopharma is highly desirable.
  • Familiarity with GMP-certified manufacturing environments is preferred.
  • Proficiency with cloud-based quality management systems, ideally ETQ Reliance.
  • Experience managing QA functions in operational sites with revenues exceeding $50 million within an ISO-certified environment.
  • Demonstrated ability to lead and develop teams in dynamic settings.
  • Experience conducting large-group engagements, such as audits and certifications.
  • Proven track record in leading cross-functional risk analyses and root cause investigations.
What We Offer:
  • Competitive compensation with a robust bonus program.
  • Comprehensive medical, dental, and vision benefits for employees and their dependents.
  • Flexible spending accounts for healthcare and childcare.
  • 401(k) retirement plan with employer matching.
  • Company-paid disability and life insurance.
  • Flexible work arrangements.
  • Enhanced parental leave policies.
  • Immediate PTO accrual.
  • Company-wide social events and recognition programs.

LGC Biosearch Technologies is committed to fostering a diverse and inclusive workplace. We value each applicant's unique talents and experiences and ensure that our hiring processes are free from discrimination.

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