Required Experience:
Considering making an application for this job Check all the details in this job description, and then click on Apply. 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 & SkillsSite 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 ABILITIESDetail‐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. xmcpwfu Light physical activity with occasional movement within production and service areas. GRN West Palm Beach9897 Lake Worth Road, Suite 202 Lake Worth, FL 33467 USA
