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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