Extremity Care - San Antonio, TX

posted about 2 months ago

Full-time - Senior
San Antonio, TX
Miscellaneous Manufacturing

About the position

The Vice President of Operations is responsible for ensuring operational efficiency across the organization, focusing on meeting budget targets and executing operations profitably while maintaining regulatory compliance. This role involves overseeing various operational aspects, including supply chain, production, quality assurance, and distribution, to achieve strategic goals.

Responsibilities

  • Define and execute operational strategies and solutions in support of organizational strategic objectives.
  • Oversee management of all aspects of operations including supply chain, production, quality assurance, distribution, planning, and equipment operations.
  • Develop operational timelines and budget forecasts, and track and deliver accordingly.
  • Oversee performance of internal management, external contractors, consultants, and vendors.
  • Manage departmental resources and budget to meet strategic goals.
  • Implement and improve operating margin processes through collaboration with team members and executive leadership.
  • Develop and implement processes for effective planning, execution, and reporting of manufacturing and distribution.
  • Ensure adherence to cGMP, GMP, GDP, FDA regulatory, quality, and customer requirements across all operational functions.
  • Support internal, client, and regulatory agency audits to ensure compliance with regulatory requirements and internal policies.
  • Develop key performance indicators to assess risk and monitor key metrics, quality, and costs.
  • Participate in the review and planning of operational functions, including evaluating hypothesis, objectives, study design, feasibility, and regulatory requirements.
  • Continuously drive operational excellence and process optimization.
  • Review and approve reimbursement requests for operational staff.
  • Build and maintain long-lasting relationships with customers, vendors, and suppliers.
  • Maintain records in accordance with standard operating procedures.
  • Manage direct reports and provide constructive feedback to develop leadership in direct reports and department management.
  • Establish and monitor objective annual goals for direct reports and conduct performance reviews.

Requirements

  • Bachelor's degree in biological science, engineering, or related field required.
  • Master's degree in biological science, engineering, business, or related field preferred.
  • At least 8-10 years of experience in an FDA regulated environment for HCT/P, medical device, and/or pharmaceutical manufacturing, with at least 5 years in an operational/quality management role required.
  • Deep knowledge of medical device manufacturing development process, GMP, quality assurance, regulatory affairs, and regulatory requirements.
  • Strong budgeting/financial skills with a proven ability in operational efficiency and cost control.
  • Strong leadership, communication, and delegation skills to drive key initiatives and objectives.
  • Excellent written and verbal communication skills.

Nice-to-haves

  • Experience with operational metrics, quality standards, and compliance requirements.
  • Proficiency with documentation, reporting, and presentations to key stakeholders.
  • Strong organizational, time-management, and project management abilities.

Benefits

  • Competitive salary range of $128K - $163K per year.
  • Full-time position with potential for overtime and weekend work as needed.
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