Senior Manager, Biocompatibility
Share
Job Location:
West Lafayette, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
Overview
The Senior Manager Biocompatibility participates in the development of and leads the implementation of the global strategy governance and compliance of biocompatibility ensuring accuracy and continuous improvement through standardized systems and processes. Leads and inspires global teams fostering a culture of collaboration accountability and high performance to ensure consistent delivery of centralized capabilities across all markets.
Responsibilities
- Responsibility for executing of all activities associated with the biocompatibility assessments testing and reporting.
- Direct and maintain a scalable global structure for biocompatibility ensuring clear communication and alignment with business objectives.
- Participate in the development of and lead implementation of a strategic vision and objectives for the global Biocompatibility team ensuring alignment with overall corporate goals regulatory requirements and operational excellence initiatives.
- Collaborate closely with global functional leadership to ensure local market needs are integrated into global strategies.
- Participate in standards committees to drive best practice in the field of biocompatibility testing.
- Manage and foster relationship with key suppliers specifically external biocompatibility test entities.
- Provide leadership and mentorship and technical expertise to a diverse geographically dispersed Biocompatibility team ensuring alignment with global standards and regional needs.
- Oversee and manage biocompatibility budgets including cost tracking and strategic planning to support global operational priorities.
- Drive adherence to relevant Quality Management Systems and Business Processes promoting a culture of quality and organizational effectiveness.
- Engage effectively with stakeholders across all levels of the global organization to foster strategic relationships influence policy and ensure compliance. Lead cross-functional collaboration to optimize Biocompatibility processes.
- Foster a high-performance culture focused on talent development succession planning and continuous improvement.
- Establish and maintain global best practices standardised policies and/or procedural controls as needed to ensure consistency accuracy and compliance of biocompatibility work outputs and systems. Balance standardization with regional flexibility where necessary.
- Champion a continuous improvement culture by leading initiatives that leverage AI and digital tools automation and innovate processes to enhance efficiency accuracy and compliance in biocompatibility activities.
- Ensure biocompatibility team members possess the requisite technical skills experience and training to perform their work.
- Provide strategic recommendations for workforce planning and contribute significantly to employee related decisions and development initiatives.
- Foster and maintain a positive inclusive and productive work environment aligned with Cooks culture and values.
- Willingness and availability to travel globally on company business.
Qualifications
- Bachelors degree in Science or Engineering and 10 years relevant experience. Relevant PhD may reduce the experience requirement by 2-4 years.
- Experience in a regulated industry in a similar role preferred.
- Demonstrated experience of executing all aspects of biocompatibility assessment and testing as well as interacting standards bodies.
- Strong leadership and team management capabilities with ability to guide and develop global teams.
- Ability to lead and deliver multiple complex global projects simultaneously within deadlines.
- Ability to develop and maintain strong working relationships with internal and external stakeholders.
- Adapt to dynamic landscapes and organizational changes with the ability to adjust quickly and effectively in a change-driven environment.
- Excellent problem-solving abilities and the capacity to work effectively both collaboratively and independently in environments with minimal supervision.
- Excellent organizational and planning abilities complemented by keen attention to detail.
- Demonstrated ability to work in a fast-paced high-pressure environment and meet deadlines.
- Collaborative team player with a proven ability to foster trust open communication and effective collaboration across diverse teams and stakeholders.
- Effective communication and interpersonal skills to build relationships across diverse geographies and cultures.
- Must be able to perform the essential functions of the job subject to reasonable accommodation requirements as applicable by country of: (i) the ADA (Americans with Disabilities Act) (USA Only); (ii) Disability Discrimination Act 1992 (Australia Only); or (iii) other applicable local regional or national law or regulation.
Required Experience:
Senior Manager
Key Skills
- Program Management
- FDA Regulations
- Management Experience
- Facilities Management
- Clinical Development
- Data Management
- Quality Systems
- Project Management
- Research & Development
- GLP
- Budgeting
- Leadership Experience
About Company
Cook Medical is a family-owned medical device company that works with physicians to develop devices that are less invasive for patients.
