Vice President of Operations

Purpose

The Vice President of Operations is responsible for operational efficiency across the organization to ensure that budget targets are met and that operations are being executed in an efficient and profitable manner to achieve strategic goals while maintaining regulatory compliance.

Responsibilities

• Define and execute operational strategies and solutions in support of organizational strategic objectives
• Oversee management of all aspects of operations within Tiger Aesthetics Medical to include (but not be limited to) the following: supply chain, production, quality assurance, distribution, planning, and equipment operations
• Develop operational timelines and budget forecasts and be accountable for tracking and delivering 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 execuive leadership, while ensuring tools and support are in place to meet objectives
• Develop and implement processes to enable the effective planning, execution, and reporting of manufacturing and distribution in support of company objectives
• Ensure adherence to cGMP, GMP, GDP, FDA regulatory, quality, and customer requirements across all operational functions
• Maintain understanding of relevant industry practices, trends, and regulatory developments to appropriately guide the practices within the organization
• Support internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, accreditation/certification requirements, and internal policies and procedures
• 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, strong relationships with customers, vendors, and suppliers
• Maintain records in accordance with standard operating procedures
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures
• Manage direct reports
• Provide constructive feedback and guidance to develop leadership in direct reports and department management
• Establish and monitor objective annual goals for direct reports
• Conduct performance reviews and establish performance improvement plans as needed
• Recruit, interview, and select personnel for hire
• Travel domestically up to 20% to attend offsite meetings, conferences, and support business initiatives
• Start job duties on time, stay on the job throughout the assigned shift to complete duties properly, and attend all scheduled meetings and appointments
• Work overtime during weekdays and on the weekend as needed to support business/operational needs
• Perform other related duties as assigned

Skills

• Deep knowledge of medical device manufacturing development process, GMP, quality assurance, regulatory affairs, and regulatory requirements
• Ability to effectively partner with business leaders to support their goals while minimizing compliance risks to the overall business
• Highest level of ethics and integrity
• Ability to lead and motivate the right behaviors
• Strong budgeting/financial skills with a proven ability in operational efficiency and cost control
• Demonstrated ability to liaise with other functions and key partners
• Strong leadership, communication, and delegation skills to drive key initiatives and objectives
• Expertise 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
• Excellent written and verbal communication skills

Qualifications/Requirements

• Bachelor’s degree in biological science, engineering, or related field from an accredited institution 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
• Clearance of favorable background investigation required