Job ID 210000RI
Available Openings 1
PURPOSE AND SCOPE:
The Sr. Manager Clinical Quality Systems is responsible for managing and executing the Clinical Quality System for FMCRTG, LLC and serves as an important conduit within the broader organization to ensure a culture of compliance through well thought out, actionable, aligned, and achievable compliance related processes Communicates and interfaces with a host of cross-functional partners, identifies key performance indicators, areas for improvement, and ensuring compliance with current regulatory policy, regulations, and guidance. The role will actively develop and implement Standard Operating Procedures, tools, and templates for application and oversight in clinical research and will provide guidance of such within Clinical Research/Operations. Additionally, this role will manage activities for clinical regulatory audits internally and externally at investigator sites, when appropriate.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Provide support to internal functions in the application, maintenance, and improvement of quality systems and specific procedures/processes used in clinical research.
Ensures adherence to Clinical QS SOPs and Policies and assuring they are accurate, up-to-date and reflect current practice and regulatory requirements.
Create, revise, and review departmental Standard Operating Procedures.
Provide review of preclinical and clinical trial protocols to ensure GLP/GCP Compliance.
Provide review and approval for process validation and laboratory methods used in GLP.
Administer Clinical Quality System training and ensure the program meets relevant regulatory requirements.
Provide direction and guidance to study teams to address quality issues, concerns, and potential regulatory compliance risks.
Maintain awareness and develop expertise of GxP requirements related to clinical research.
Serve as clinical quality subject matter expert (SME) for regulatory inspections.
Assist with audit and inspection activities (preparation, conduct, and response) for clinical regulatory inspections (internal and at investigator sites).
Provide regular updates to senior management and participate in the resolution of quality issues in clinical research.
Provide leadership in cross-functional teams to identify and address compliance risk areas related to clinical research.
Implement, perform, and maintain clinical quality systems:
Clinical/Pre-Clinical corrective and preventive action (CAPA) process
Clinical/Pre-Clinical documentation process
Clinical/Pre-Clinical management review process
Clinical/Pre-Clinical quality project management
Clinical/Pre-Clinical supplier quality management
Clinical quality due diligence and acquisition management, as needed
Clinical/Pre-Clinical inspection/audit readiness support
Clinical/Pre-Clinical quality improvement projects
Set strategic direction of Clinical Quality Systems Compliance
Conduct presentations on quality issues and initiatives at cross-functional meetings
Develop and conduct training
Develop and report Quality and Compliance metrics related to Clinical Quality Systems
Determine escalation procedures for issues arising from Clinical Quality Systems Compliance
Coach/mentor staff as a means to ensure performance and professional development
Establish/maintain effective cross-functional team communications
May escalate difficult/complex issues to supervisor/manager for resolution, as deemed necessary.
Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action.
Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
Assist with various projects as assigned by direct supervisor.
Provides leadership and coaching to all direct reports and partners with human resources on employee matters.
Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Travel required: 10-30% in support of clinical audits, investigator site audits and vendor/supplier audits
- May be responsible for the direct supervision of various levels of Clinical QS staff.
- Bachelor's Degree required; Advanced Degree preferred.
EXPERIENCE AND REQUIRED SKILLS:
- Minimum 6 – 8 years' related experience.
- Certification as a Clinical Research Professional is desired.
- 3+ years' experience as a Manager preferred.
- Laboratory experience required for toxicology review, process validation, and laboratory methods.
- Strong understanding of good manufacturing, clinical, and laboratory practices
- Background in Quality Systems, with experience in clinical quality assurance or clinical quality systems group serving in a quality role desired.
- High attention to detail.
- Excellent communication and writing skills; excellent group and facilitation skills, professional with high personal integrity and ability to develop good interpersonal relationships with healthcare professionals.
- Good analytical, conceptual and problem-solving skills to evaluate business problems and apply knowledge to identify appropriate solutions; ability to resolve associate issues effectively and efficiently.
- Effective interpersonal skills, including high energy level and creativity.
- Strong relationship building, consultative and influencing skills.
- Expertise in writing and revising Standard Operating Procedures
- Proven ability to manage projects/teams of significant scope/complexity while meeting milestones.
- Excellent organizational skills; ability to manage aggressive timelines and pay close attention to detail; analytical.
- Excellent ability to train, develop and motivate QS Compliance department staff.
- Demonstrated ability and history of operating as an effective manager/leader.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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