Grifols Shared Services North America, Inc Quality Compliance Manager / Sr. Manager in Clayton, North Carolina
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
Primary responsibilities for role:
Host worldwide regulatory agencies during site inspections and must be fluid at cultural appreciation in such interactions, as well as the technical content under discussion.
Plan and analyze workflow, delegate and prioritize, to ensure process and documentation reviews and projects are completed in a timely manner.
Review and evaluate inspection/audit CAPAs to ensure robust and effective commitments/responses are determined such that repeat events do not occur.
Conduct routine industry and regulatory surveillance in order to keep GT aligned with changing worldwide regulations.
Design, develop, improve, and implement Quality systems throughout the manufacturing site, leveraging quality risk management principles.
Provide technically sound reviews of quality agreements associated with product as well as with services.
Partner with Grifols BioSupplies group to fully support (via agreement reviews, audits, etc...) non-therapeutic use contracts.
Provide critical scientific, cGMP, and technical support to GT as well as work towards harmonization with the other Grifols BioScience sites.
Direct the supplier management program and impact to GT operations, in coordination with Grifols Global Sourcing and other Grifols BioScience sites.
Ensure a robust system for review of supplier change notifications and timely determination of any impact to the manufacturing process or products.
Oversee the materials clearance program for GT products/process, verifying only acceptable materials are utilized for commercial production.
Have demonstrated skills in managing projects to bring in on budget, on schedule, and technically/cGMP correct.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Knowledge, Skills & Abilities
Must have an in-depth knowledge and application of US, EU, PIC/s, and other world-wide regulations.
Must thrive working in a fast-paced environment while remaining flexible, proactive, resourceful, and efficient.
Must have excellent interpersonal skills, good conflict management and negotiation skills, and the ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations.
Must have a demonstrated ability to translate strategy into action with the necessary sense of urgency, excellent analytical skills, and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Proficiency in Excel, Word, Powerpoint, and SAP is required.
American Society of Quality CQA certification is preferred.
Requirements by level:
Quality Compliance Manager
PHD in a Life Sciences or relevant degree with minimum of 6 years relevant experience OR MS in a Life Sciences or relevant degree with minimum of 8 years relevant experience OR BS in a Life Sciences or relevant degree with minimum of 10 years relevant experience.
Sr. Manager Quality Compliance Manager
BS/BA degree with a minimum of 7-10 years experience working in a Quality Assurance/FDA-regulated facility.
Minimum 5 years hands on management experience.
Thorough knowledge of cGMP regulations and regulatory inspection requirements.
Experience in dealing with the FDA regarding license submissions, inspections and audit follow-up required.
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.
Req ID: 335919