Purpose
The Vice President of Operations is responsible for bioCARE and accountable for efficiency within the tissue collection area and ensure that supply goals are met and that raw goods are being delivered timely. The Vice President of Operations must be tech and systems savvy, and highly skilled in business acumen, project management, data analysis, and driving metrics in tissue recovery. The Vice President of Operations will be expected to ensure the highest quality standards for documentation, recovery and packaging, staff training and equipment maintenance. Must possess the ability to handle multiple priorities and address present concerns while keeping an eye on future opportunities.
Duties & Responsibilities
- Maintains a working knowledge of all tissue recovery processes, donor eligibility criteria, regulations and standards, and processor requirements.
- Ensures the development of all learning modules is relevant and effective and accomplished in a timely manner.
- Assists with organizing and conducting tissue recovery trainings.
- Investigates and documents all reports of adverse outcome/ reactions.
- Develop and maintain standard operating procedures and policies (SOPs) and validation plans and ensures timely training and implementation of each project and plan. This includes development of tissue donor preparation and recovery, laboratory and participation in the development of donor chart and case management SOPs.
- Investigates, develops and implements new tissue service processes.
- Develop key performance indicators (KPIs) to assess risk and monitor key metrics, status, quality and costs.
- Developing specific tissue services statistical reports.
- Directly supervises the designated staff to perform effective quality oversight of employees and processes designated as their direct reports or responsibilities.
- Work with the Director of Quality Assurance to ensure that BioCare complies with all quality processes, helps respond to all external and internal audits, and customer service issues, and assists in implementing corrective and preventive actions in relationship to performance and quality issues.
- Ensures that appropriate technical staff is prepared for certification/recertification by the American Association of Tissue Banks (AATB).
- Reviews all hiring decisions, performance appraisals, and notices of corrective action with the Human Resources Department prior to taking final action with the prospective new or current employees.
- Conducts periodic meetings with staff and ensures all agendas and minutes are documented and filed for all meetings.
- Ensure adherence to GMP, regulatory, quality and partner requirements across all product development functions.
- 20% or more domestic travel may be required.
- Report to work in-person and start job duties on time for established shift.
- Complete required hours on assigned works shift to complete assigned responsibilities and duties
Skills & Abilities
- Deep knowledge of tissue recovery process, GMP, quality assurance, regulatory affairs, product development and global regulatory requirements.
- Ability to influence decision making without direct reporting authority.
- Ability to effectively partner with business leaders to support product development 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, efficiency, and cost control.
- Demonstrated ability to liaise with other functions (operations, regulatory, quality, finance, etc.) and key partners.
- Strong leadership, communication, and delegation skills to drive key initiatives and objectives.
- Proficiency with documentation, reporting, and presentations to key stakeholders.
- Strong organizational, time-management, and project management abilities.
- Excellent written and verbal communication skills.
- Ability to secure and maintain a favorable background investigation and clearance.
Education & Experience
- Bachelor's degree in sciences, finance, or business field required.
- Master’s degree in sciences preferred.
- 5-10 years of experience in tissue recovery management, quality assurance, regulatory or relevant cross functional role.
