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