This position does not have direct reports, but will have the opportunity to work with teams across the globe. This is a great opportunity for someone who has not been at a manager level previously to get project leadership experience in a dynamic environment.
JOB SUMMARY
Under general guidance from the Sr. Global Quality Management Systems Manager, The Global Quality Management Systems Manager will work to harmonize ILC Dover LP Management Systems through regions and business units. The incumbent will be responsible for ensuring Management System processes are documented, implemented, and achieving the intended results throughout the organization. The Global QMS Manager will work within the eQMS system and with the Site and Global Quality team members to continuously create, establish and maintain the system modules for Deviations, CAPAs, Non-Conformances, Risk Assessments, Change Control, Internal Audits, and Records Management. The QMS Manager is responsible for ensuring a robust, sustainable, and effective Quality Management System (QMS), and to ensure that operations are in full compliance with standards and policies.
Key Responsibilities:
- Lead and or participate in 3rd party and customer audits
- Lead and or participate in regulatory inspections
- Collaborating with ILC sites and global teams to ensure ISO and other requirements are adhered to throughout the organization
- Document global Processes and Procedures that meet the requirements of ILC, Regulatory, Statutory, Customers, and Certifying bodies
- Work with functional Global and Site Leaders to revise and develop BMS documents to ensure meeting of requirements
- Provide organization guidance and training on system related processes and requirements
- Lead and or participate in Global Deviation and Change Managements
- Lead cross functional teams to ensure robust risk management activities
- Manages local change control practices, ensuring all planned changes are documented per procedure, links changes to risk management processes, and routinely reviews the progress of changes and closes out when completed.
- Implements and manages global procedures to effectively manage corrective and preventative action plans. Tracks and reviews CAPA plans on a routine basis and ensures they are effective across the sites. Lead and or participate in Global CAPA meetings
- Manages the internal audit program, ensuring that the schedule is robust to reflect critical processes and is maintained throughout the year by trained staff.
- Promotes QMS Management principles and drives continuous improvement across quality standards, requirements, and best practices
- Manages QMS improvements including system migrations when applicable
- Perform other duties as assigned by the Quality Director or Manager
QUALIFICATIONS:
- Bachelor’s Degree or equivalent experience preferred with five (5) years’ minimum experience in the Pharmaceutical/Medical Device Industry with a primary focus on working in a Quality Assurance capacity.
- Experience and knowledge of FDA Quality System Regulations and ISO Standards
- Knowledge of US FDA and European GMP requirements and associated guidelines
- Knowledge of FDA 21 CFR regulations, ISO 9001, ISO 13485, and FSSC 22000 requirements preferred. Experience in a clean room environment preferred.
- Experience in conducting risk assessments and applying a risk-based approach to production and processes.
- Experience in documentation creation and control to support quality and production requirements.
- Knowledge across different elements of a QMS in a regulated environment
- Professional written and verbal communication skills. Ability to deliver clear communications to inform, educate, and influence at varying levels of the organization.
- Good collaborator with demonstrated ability to work well in cross functional teams and develop working relationships with stakeholders at every level of the organization
- Effective time management skills with the ability to multitask and work under pressure.
- Self-motivated, with an ownership mindset who is detail and results oriented
- Flexible thinking skills with the ability to challenge and see views from different perspectives
- Possess strong technical computer skills with proficiency in using various computer programs and web-based applications, including Microsoft Word, Excel, PowerPoint, SharePoint, Visio
Work Environment:
The 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.
While performing the duties of this job, the employee is frequently exposed to work near moving mechanical parts; occasionally exposed to fumes or airborne particles; and chemicals or solutions. The noise level in the work environment is usually moderate.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee regularly sits, stands and walks. The employee occasionally lifts and/or moves up to 20 pounds. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel and talk or hear. The employee is frequently required to reach with hands and arms. The employee will regularly use visual attention, eye focusing, visual perception. The employee will regularly use reason, logic, and critical-thinking skills.
Background Check & Drug Screening Required
E-Verify Used
EOE/AA Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran
Applicants with a disability that need assistance applying for a position may email hr@ilcdover.com
