General Manager-Head of Operations, Diagnostics-TX 9056-3445

Global Recruiters of West Palm Beach; Town of Texas (WI); On-site; USD 140,000 - 210,000; Full time

Job summary

A rapidly growing global medical diagnostics company is searching for a General Manager-Site Director for its Texas facility. This leadership role requires a minimum of 7 years in site management within regulated manufacturing. The successful candidate will oversee all operations, ensure compliance with quality standards, and drive strategic growth. The position entails leading multi-functional teams and requires strong analytical and communication skills. A Master's degree is required, with a preference for additional advanced qualifications.

Qualifications

• Minimum 7 years of experience in site management or senior operations leadership within regulated manufacturing.
• Demonstrated ability to lead multi-functional teams.
• Solid understanding of ISO-based Quality Management Systems.
• Solid understanding of ISO-based Quality Management Systems (ISO 13485 / MDSAP preferred).
• Strong analytical, organizational, and problem-solving skills.
• Excellent written and verbal communication skills in English.

Responsibilities

• Lead all operational and strategic functions of the Texas site.
• Ensure compliance with quality standards and regulations.
• Make operational financial decisions regarding budgets.
• Develop and execute long-term strategic goals for the Texas site in alignment with the company’s Group strategy.
• Support growth of the site’s CMO diagnostics business and external customer partnerships.
• Ensure compliance with quality standards, regulatory requirements, and QA/RA alignment.
• Oversee budgeting, cost control, and capital expenditures.
• Coordinate site execution with QA/QC, Finance, HR, and IT.

Skills

Leadership

Operational Excellence

Analytical Skills

Problem-Solving

Communication

Regulatory compliance

ISO 13485 knowledge

MDSAP knowledge

Financial management

Budgeting

Capital expenditure

Cross-functional collaboration

People management

Lean / Six Sigma

English communication

Education

Masters Degree in Engineering, Business Administration, Life Sciences

Job description

Required Experience

Minimum 7 years of experience in site management or senior operations leadership within regulated manufacturing (medical devices, diagnostics, biotech).

Required Education

Masters Degree in Engineering, Business Administration, Life Sciences.

Job Description

A rapidly growing global medical diagnostics company, specializing in point‑of‑care testing, central laboratory diagnostics, enzyme manufacturing, and contract manufacturing services for the healthcare industry, is seeking a General Manager‑Site Director‑Diagnostics for its facility in Texas. The General Manager‑Site Director‑Diagnostics will lead all operational and strategic functions of the Company’s Texas site, reporting directly to the Chief Operating Officer.

Knowledge & Skills

• Site Leadership & Operational Excellence
  • Provide overall direction and leadership for all Texas site operations including manufacturing, engineering, facilities, supply chain, and service/repair.
  • Establish a culture of accountability, teamwork, and continuous improvement.
  • Implement site KPIs to enhance structure, performance, and productivity.
• Strategic Development & Group Alignment
  • Develop and execute long‑term strategic goals for the Texas site in alignment with the company’s Group strategy.
  • Support growth of the site’s Contract Manufacturing Organization (CMO) diagnostics business and external customer partnerships.
  • Ensure strong collaboration with the company’s global leadership and other manufacturing sites.
• Quality, Compliance & Regulatory Standards
  • Ensure compliance with applicable quality standards, regulatory requirements, and the company’s procedures.
  • Partner closely with QA/RA and QC leadership to maintain audit readiness and continuous improvement.
  • Promote patient safety and product integrity across all operations.
• Financial & Business Responsibility
  • Make operational financial decisions regarding budgets, cost efficiency, and capital expenditures.
  • Drive operational performance to meet delivery, cost, and profitability targets.
  • Contribute to sustainable site growth and long‑term competitiveness.
• Cross‑Functional Collaboration (Dotted Line Functions)
  • Coordinate site execution in partnership with Quality Assurance / Quality Control, Finance, Human Resources, and IT.
  • Ensure site priorities are supported while maintaining global functional standards.
• Other Functions
  • Ensure compliance with safety regulations and procedures; maintain a clean and safe working environment.
  • Support additional company initiatives as required.
  • Perform other duties as assigned.
• Supervisory Responsibilities
  • Direct management responsibility for site Operations, Manufacturing, Engineering, Facilities, and Service/Repair teams.
  • Dotted‑line coordination with Quality, QC, Finance, HR, and IT.
  • Responsibilities include hiring, training, performance management, coaching, and employee development in accordance with the company’s policies and applicable laws.

Travel

Occasional travel may be required.

Work Experience, Skills and Education Required

• Masters Degree in Engineering, Business Administration, Life Sciences, or related field.
• Minimum 7 years of experience in site management or senior operations leadership within regulated manufacturing (medical devices, diagnostics, biotech).
• Demonstrated ability to lead multi‑functional teams and drive operational excellence.
• Solid understanding of ISO‑based Quality Management Systems (ISO 13485 / MDSAP preferred).
• Strong analytical, organizational, and problem‑solving skills.
• Excellent written and verbal communication skills in English.

Preferred Qualifications

• MBA or advanced degree.
• Experience in Point‑of‑Care consumables manufacturing.
• Background in CMO/customer‑facing manufacturing operations.
• Lean / Six Sigma Certification.
• International leadership experience within a global matrix organization.

BASIC SKILLS AND ABILITIES

• Detail‑oriented with strong accountability and ownership mindset.
• Ability to manage multiple priorities in a fast‑paced environment.
• Proven leadership and mentoring skills with a collaborative management style.
• Strong ability to interpret business, technical, and financial information.

PHYSICAL DEMANDS & WORK ENVIRONMENT

• Primarily office and manufacturing site environment.
• Must be able to wear PPE as required.
• Light physical activity with occasional movement within production and service areas.

GRN West Palm Beach

9897 Lake Worth Road, Suite 202
Lake Worth, FL 33467 USA