Director, Bioresearch Quality Process Management

Role Overview

• Directly responsible and accountable for supervision and development of direct reports.
• Develop and implement an integrated bioresearch quality strategy that aligns proactive risk management and MedTech organizational goals to enable process optimization and innovation.
• Lead the quality process management team to promote a culture of quality and continuous improvement.
• Strategic oversight of activities and functions responsible for providing centralized visibility and reporting on risk data reporting.
• Ensure MedTech R&D Quality Bioresearch procedures comply with industry regulations (e.g., FDA, ISO) and internal policies.
• Design and optimize scope of Bioresearch R&D Quality processes and drive risk insights, including Clinical Risk Management, Bioresearch Audits, NC/CAPA/Escalation through cross-functional collaboration within R&D Quality MedTech Bioresearch, MedTech Q&C functions, Subject Matter Experts and cross functional business partners.
• Identify areas of improvement and implement best practices including business development due diligence, clinical risk management, integration and inspections for bioresearch quality.
• Responsible for driving innovation and continuous improvement in portfolio bioresearch quality activity processes.
• Establish and utilize data analytics through digitalization and AI to monitor quality metrics and drive decision-making of bioresearch quality activities.
• Prepare reports for senior management on quality performance and improvement initiatives.
• Enable cross Business Unit governance of bioresearch quality risks, mitigations and sharing of best practices.
• Oversee the development of training programs for staff on bioresearch quality processes and compliance requirements to ensure a knowledgeable workforce.
• Establish and enable sharing of best practices through communities of practice across MedTech Businesses.
• Establish potential risks in pre-clinical/clinical/Med Safety/PV quality systems and processes and implement mitigation strategies to minimize impact and drive innovation.
• Responsible for owning the process to provide centralized insights on risks, on portfolio quality activities, and reporting processes.
• Establish and maintain strong relationships with internal and external stakeholders to advocate for Bioresearch quality and process excellence.
• Establish process for visibility to activity drivers and portfolio.
• Ownership of creating and maintaining central visibility for budget planning, prioritization and value creation.

Requirements

• A minimum of 10 years working in regulated environments
• Ability to effectively apply project management tools and lean methodologies when leading projects and programs
• Excellent leadership skills, self-starting/motivated with highly developed interpersonal and teamwork skills
• Ability to quickly process and communicate complex information and make critical decisions with limited information
• Experience with strategy execution and implementation, and reporting to executive level leadership
• Experience influencing or persuading others to accept new ideas, approaches, or concepts or gains alignment on divergent issues with limited guidance
• Experience with Integrations, Clinical quality processes and procedures and systems, including remediation efforts
• Established trusted leadership, anticipating business needs and proactively takes actions; leverages relationships; develops strategic alliances
• Big picture orientation with attention to detail and results oriented
• Ability to work in a matrix and multi-cultural environment
• Preferred: Leadership in digitalization initiatives and AI application/products
• Established expertise or experience in process excellence or design, clinical risk management, and process management

Benefits

• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
• Vacation –120 hours per calendar year
• Sick time
• 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time
• up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year