Associate Vice President, Program Management & Technical Operations

Cerapedics•Westminster, CO

1d•$230,000 - $270,000•Onsite

About The Position

ABOUT US Cerapedics is a global, commercial-stage ortho-biologics company that aspires to transform the standard of care for bone repair, healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest life. Bone grafts, including Cerapedics' products, are used in over four million annual spine, orthopedics, trauma and interventional procedures world-wide. Cerapedics' product, i-FACTOR, is FDA PMA approved for cervical use in the United States. Cerapedics' next-generation product is currently being evaluated in lumbar interbody fusion through ASPIRE, a pivotal FDA IDE study and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO. OVERVIEW Healing lives through bone repair - this mission is what inspires us every day. If that is inspiring to you as well, consider joining us as an Associate Vice President, Program Management & Technical Operations in our Westminster office. In this role, you will contribute to our mission through overseeing areas of the business that impact product compliance, appropriate product specifications, and ensure that external and internal compliance changes are incorporated into best practices and functions within the organization. As an Associate Vice President, Program Management & Technical Operations working on the Operations team, you will be empowered through meaningful work and career development as a key member of the leadership team and are responsible for overseeing all Program Management supporting several functions in the company including but not limited to commercial, operations, manufacturing, organizational and departmental long-range planning and strategy, and infrastructure. A typical day will include overseeing the Technical Operations department to ensure uninterrupted operations between and across various functions including external suppliers, R D, manufacturing, quality, etc. POSITION OBJECTIVES: Responsible for ensuring that any changes (e.g., raw materials, regulations, equipment, process) meet requirements (e.g., FDA, BSI, quality systems). Only after the requirements are met can manufacturing incorporate changes and ensure continuity of product supply. External Vendors : Manage all critical partners so that we can proactively manage changes. Internal Processes : Ensure all changes including raw materials from non-critical vendors, process changes, equipment changes, etc. meet requirements. External Standards : Monitor changes in regulations and standards and ensure that we have done all the work to ensure that our products are compliant. Develop internal processes that audit changes made by vendors to ensure compliance. Strategize and develop the sourcing function by evaluating different vendors, including dual sourcing of key components. Ensure that external and internal changes meet specifications and conform to industry standards. Build, mentor and lead a high-performing Program Management and Technical Operations team. Foster a culture of continuous improvement, professional development and inclusion. Develop and maintain project plans, schedules, budget, ad hoc analysis and resource tracking for assigned projects. Ensure timely and effective stakeholder communication on progress and potential issues. Develop project risk management plans and ensure key risks are mitigated, and additional resources identified to ensure successful project execution. Ensure alignment between core teams and stakeholders.

Requirements

Communicate succinctly, clearly and accurately in both verbal and written communications.
Experience in managing publications, medical writing, and external scientific communications.
Ability to manage timelines, multiple priorities under time constraints.
Aptitude to develop technical expertise in new therapeutic areas.
Strong analytical and problem-solving skills.
Ability to work effectively in a cross-functional, fast paced, rapidly changing environment.
Must be self-motivated, assertive and able to approach with a positive ‘can-do' attitude.
Ability to cultivate and maintain relationships with thought leaders and to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through requests from thought-leaders.
Strong leadership skills and the ability to compile and disseminate information to others in a cohesive fashion to ensure a clear understanding of project status and direction.
Excellent communicator, skilled at diplomacy, tactful and capable of effectively combining technical aptitude and relationship building for internal and external Company stakeholders.
Advanced in Excel, PowerPoint, and Project and Program Management tools and resources like Power BI, Microsoft Project and other Project Management Software tools.
Bachelor's degree in engineering, scientific or related field (required)
Minimum of 12 years of relevant work experience with progressively increasing responsibility or complexity of organizational strategy, program and technical leadership.
Minimum of 10 years leading programs and projects in a medical device, biomedical, pharmaceutical, or high technology industry.

Nice To Haves

Experience with orthopedics or spinal medical devices is highly desirable.
Advanced degree or MBA (preferred).

Responsibilities

Responsible for ensuring that any changes (e.g., raw materials, regulations, equipment, process) meet requirements (e.g., FDA, BSI, quality systems).
Manage all critical partners so that we can proactively manage changes.
Ensure all changes including raw materials from non-critical vendors, process changes, equipment changes, etc. meet requirements.
Monitor changes in regulations and standards and ensure that we have done all the work to ensure that our products are compliant.
Develop internal processes that audit changes made by vendors to ensure compliance.
Strategize and develop the sourcing function by evaluating different vendors, including dual sourcing of key components.
Ensure that external and internal changes meet specifications and conform to industry standards.
Build, mentor and lead a high-performing Program Management and Technical Operations team.
Foster a culture of continuous improvement, professional development and inclusion.
Develop and maintain project plans, schedules, budget, ad hoc analysis and resource tracking for assigned projects.
Ensure timely and effective stakeholder communication on progress and potential issues.
Develop project risk management plans and ensure key risks are mitigated, and additional resources identified to ensure successful project execution.
Ensure alignment between core teams and stakeholders.