Grifols Shared Services North America, Inc Senior Manager, Regulatory Compliance in RTP, North Carolina
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Manages and oversees activities required to ensure Plasma donor center and plasma facilities' inspection readiness and subsequent compliance with Domestic (FDA, CLIA/COLA, PPTA, State), European (EU) and ROW (Rest of World) regulations. Work with Senior Director to oversee external regulatory compliance objectives within entire company, including related projects and continuous improvement.
Leads team of Managers and Quality Compliance Specialists (QCS) to facilitate pre-inspection (scheduling, site master file), during (coordination, interaction with agencies, updates, issue resolution) and post-inspection (CAPA formulation, response writing) activities associated with Domestic, ROW and EU competent authority inspections of GPO facilities
Be an integral part of the group,and manage quality and compliance-based projects throughout company as part of a continuous improvement effort.
Oversees facility approval process in order to obtain regulatory approval for new facilities for the final inclusion of these faculties into the Plasma Master File.
Develop and maintain database(s) to track and monitor all regulatory aspects of the plasma facilities within company.
Manage Plasma Master File updates, working closely with Biomat
Oversee and coordinate preparation of company facilities for readiness to regulatory agency inspections
Oversee and coordinate preparation and /or write responses to inspection findings related to FDA, COLA/CLIA, PPTA, customer and EU regulatory agencies. Work actively with other members of the organization. Finalize and review responses.
Manage, develop and lead activities of managers and QCS, including work duties, adequate training, inspection calendar scheduling
With collaboration with Senior Director, routinely provide guidance to center and/or business unit leadership for routine and/or complex quality compliance issues/questions
Oversee and manage (or assign to team) the various Regulatory Compliance tools utilized
Write/revise Change Requests, SOPs or other documents as needed
Prepare and distribute (or oversee) monthly trending reports and metrics to senior management regarding regulatory inspections and quality compliance issues
Coordinate (or oversee) company activities with regard to Proficiency Testing in relation to AAB certificatio
Work closely with other team leaders to ensure a well-rounded approach to all aspects of regulatory and quality compliance within the company
Education and Experience
A BS degree is required, with a preference for an MS degree in a related field.
Typically requires a minimum of 5 years of related experience, preferable with a pharmaceutical background. Project or technical leadership experience required. Supervisory or management experience required. Experience with Quality systems and Regulatory Compliance is desired. Plasma industry experience is beneficial.
The incumbent must have the ability to write clear, concise, logical responses to regulatory authorities. They must understand and/or be familiar with the Code of Federal Regulations (CFR) as it applies to Source Plasma. They must be familiar with the European Pharmacopoeia (EP) and other European Guidelines as it applies to Source Plasma and the interaction between the CFR, the EP and the company's SOP manual(s). They must be familiar with CLIA/COLA, PPTA and other (e.g. state) regulations as they pertain to Source Plasma. They must have strong interpersonal skills with the ability to communicate effectively with persons from other cultures and other points of view. Project management. Corrective Action and Preventative Action (CAPA) systems. Previous experience should demonstrate expertise in cGMPs, FDA regulations, SOP implementation and an understanding of quality principles. Ability to highlight areas for improvement to process/product. Conflict resolution skills including persuasive management techniques required. Strong oral and written communication skills needed. Excellent interpersonal skills required. Ability to manage staff not directly reporting to the position. Must be able to multi-task and work independently with little direct oversight on a day-to-day basis while producing expected results. Ability to produce effective presentations and execute the messages to multiple levels of staff.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 69818
Type: Regular Full-Time
Job Category: Quality