The Sr. Manager, Clinical Quality Risk Management Lead for Surgery advances the Clinical Quality Risk Management (CQRM) objective, overseeing a robust GxP Quality Management System to enable a diverse portfolio of medical device health products and services within the Surgery Business.
This individual serves as a subject matter expert, providing guidance on compliance-related activities across the business units in Good Clinical Practices (GCP) and/or Good Documentation Practices (GDP).
Oversees the establishment and execution of a Quality Management System (QMS) to ensure compliance of Bioresearch with applicable regulatory requirements, enterprise standards, and company policies and procedures.
Oversees the overall clinical quality risk management of the Surgery MedTech Business.
Works across teams to ensure the coordination of the identification, assessment, and mitigation of clinical quality risks that could have an impact on trial data integrity, patient rights, safety, or well–being.
Independently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews.
Independently leads key inspection processes and inspection tools to maintain an ongoing inspection readiness with trial teams to develop inspection narratives, identify and prepare sites of interest for inspection (including pre-inspection visit support), ensure availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams.

Requirements

BA/BSc or equivalent (Scientific, medical, or related discipline) is required
A minimum of 10 years of experience working in the healthcare or regulated industry (MedTech, pharmaceutical industry, contract research organization and/or healthcare/hospital system, health authority, etc.)
Excellent interpersonal, oral, and written communication skills
Proven strong Good Clinical Practices quality and/or clinical trials experience
Experience collaborating in a cross-functional team environment
Flexibility to respond to changing business needs
Demonstrates ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures.
Proficiency in Microsoft Office Applications
Available for 25% domestic and international travel.

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)).
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 period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Good Clinical PracticesGood Documentation PracticesQuality Management Systemclinical trialsrisk managementinspection readinessdata integrityregulatory compliance

Soft Skills

interpersonal skillsoral communicationwritten communicationcollaborationflexibilitycultural awareness