Vice President of Molecular Diagnostics

2 days ago

Chicago IL United States KNG Technical Inc. Full time

Department Name: Manufacturing Management

Location: USA

Summary:

The VP of Molecular Diagnostics is a leadership position responsible for:

  • All aspects of Molecular Diagnostics assay product realization at multiple sites leading to the production of safe, effective, and compliant IVD and RUO products, including the current assay portfolio.
  • Span of control that includes manufacturing, quality control, and design transfer functions and responsibilities.
  • Ensuring quality and production requirements for all associated operations, including facilities, resources, and equipment to fulfill the business plan. Assay manufacturing operations span from oligo/reagents manufacturing to non-automated and sample-to-answer assay products.
  • Financial and operational metric performance, adherence to cGMP requirements, management of direct reports and their staff, and development of strategic plans.

Key Responsibilities & Duties:

  • Direct, plan, and perform manufacturing operations and manage associated personnel.
  • Ensure compliance with corporate guidelines and procedures, as well as FDA regulatory requirements and applicable domestic and international standards.
  • Develop and execute plans and resource requirements to ensure production output aligns with the business plan.
  • Implement strategic direction for operations to ensure readiness for new product introductions.
  • Manage product and production changes necessary to ensure product availability, support, and compliance.
  • Plan and implement business process optimization and lean initiatives to eliminate waste and enhance control, responsiveness, and flexibility.
  • Pursue efficiency improvements and cost reduction efforts consistent with corporate goals.
  • Oversee the production process and evaluate adequacy for proper regulatory reporting and/or product recalls.
  • Lead planning and delivery of global business process integration, improvement, and harmonization initiatives.
  • Establish and drive execution of annual performance commitments aligned with Global Manufacturing and company objectives.
  • Manage annual departmental capital, headcount, and expense budgeting requirements.
  • Develop business system strategies and implementation.
  • Ensure effective prioritization, investigation, and resolution of findings impacting the Manufacturing operation identified through audits, non-conformances, corrective/preventive actions, or customer complaint escalation.
  • Collect, analyze, and present operational quality and performance data.
  • Engage with cross-functional stakeholders and key business partners across the company to effectively support operations.
  • Other duties as assigned.

Education and Experience:

  • Minimum Master’s degree with more than 10 years of related experience and/or training, or equivalent combination of education and experience.
  • At least 10 years of experience in manufacturing and quality in the diagnostics or medical industries.
  • Experience in an FDA regulated industry and/or an ISO certified organization.

Training, Skills and Certifications/Licenses:

  • Ability to work independently and with minimal supervision.
  • Highly organized with proven time management and prioritization skills.
  • Ability to handle the pressure of meeting tight deadlines.
  • Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
  • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
  • Ability to effectively present information to top management, public groups, and/or boards of directors.

Work Conditions:

  • Work location: US
  • Travel: 30% domestic, 10% international
  • Work is typically performed in an office environment in an industrial manufacturing setting with chemical, biological, laser, and noise hazards.
  • Physical Demands: All positions require standing, stooping, bending, climbing, sitting, kneeling, and lifting of at least 10 lbs. Additional physical requirements include lifting up to 50 lbs.
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