Manager, Quality Audits

GRIFOLS, S.A.•NC-RTP, CA

2d•Hybrid

About The Position

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Summary: Supervises a team of Quality Audit Specialists and oversees activities required to ensure center inspection readiness and subsequent compliance with Domestic regulations, European regulations, and requirements of Other Customers/Affiliates. Responsible for the management of the external audit program for Biomat USA and the collaboration with Grifols Corporate Quality to ensure alignment throughout the organization.

Requirements

The incumbent must have the ability to write clear, concise, logical responses to regulatory authorities.
Must understand the Code of Federal Regulations (CFR) as it applies to Source Plasma.
Must know 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).
Must have strong interpersonal skills with the ability to communicate effectively with people from other cultures and other points of view.
A BS degree with a preference for an MS degree in a life science field.
Typically requires a minimum of 4 years of related experience.
Project or technical leadership experience required.
Supervisory or management experience preferred.
Experience with Quality systems and Regulatory Compliance is desired.
Plasma industry experience is beneficial.

Responsibilities

Leads team of Quality Audit Specialists to facilitate pre-inspection, during and post-inspection activities associated with both domestic and EU competent authority inspections of Biomat Donor Centers and other parties, such as testing laboratories, warehouses, etc.
Supports donor centers with customer audits, completes requested customer-driven documents, and assists with development of audit responses.
Coordinates and organizes final responses to regulatory inspections / audits (FDA, EMA, CLIA/COLA, PPTA, State, Health Canada, internal compliance audits), including submission to the relevant Authority.
Manages and leads activities the Quality Audit Specialists, including work duties, adequate training, inspection calendar scheduling to ensure efficient inspection process for the facility being inspected
Oversees completion and review of Site Master Files and provides training for preparation and maintenance of this documentation
Hosts and/or coordinates staff coverage of plasma donation center inspections for European regulatory authorities. Interacts with Regulatory Agencies as needed.
Oversees and coordinates preparation of responses for both domestic and EU audits/inspections. Ensures the final response is acceptable and representative of the Grifols organization.
Provides and develop ongoing updates to European regulatory authorities to key stakeholders, including Sr. leadership.
Updates and maintains (or assigns to team) Regulatory Compliance Database (e.g. Uploading of documents (SMFs, responses, reports), maintenance of tools, etc.)
Coordinates responses, concerns and commitments with other functional areas to ensure the organization is meeting FDA, EMA and other regulations. Ensure commitments are met by the company.
Write/revise Change Requests, SOPs or other documents as needed
Works closely with Sr. Leadership to ensure that regulatory risks are mitigated in an expedited manner through active and effective communication. Communicates with Grifols Corporate Quality to ensure alignment across business units related to regulatory findings.
Performs (or assigns to team) additional tasks set by the Associate Director, when needed (e.g. Side projects, additional inspections, etc.) which may include travel up to 50%