Grifols Shared Services North America, Inc Director, Quality Assurance in San Diego, California
Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
The Director of Quality (Technical Director) is responsible for ensuring the establishment, maintenance and effectiveness of the Quality Management System according to the requisitions and policies applicable to both Grifols Corporate and Grifols Diagnostics Industrial Diagnostic Division for the San Diego site. This position accounts for the safety, purity and efficacy of the products where GDSSD is the legal manufacturer and for ensuring the Quality of the NAT products. The technical Director (Director of Quality) in this evolving business should not be solely an expert in Quality and Regulatory but should also understand how Quality supports the success of the products in the marketplace.
This position will also help lead the San Diego Quality organization in maintaining the highest Quality standards and will help guide the organization as a whole. This Director of Quality (Technical Director) position will oversee operations for four main Quality functions: Manufacturing QA (product, production, lot release), Quality Control, Quality Systems, New Product QA and Complaints/post marketed product support. This is to ensure that the operations of each department are defined and aligned with Grifols corporate, divisional and functional metrics as well as quality objectives. This may entail championing continuous quality initiatives to effect desired change. This position is responsible for Quality for the San Diego site. This position also serves as the Grifols Management Representative for San Diego site with the authority and responsibility for executing the regulatory compliance requirements outlined in FDA, World Wide Competent Authorities and Notified Bodies and ISO and non- regulatory guidelines.
This is a full time position located in San Diego, CA, reporting to the Head of Quality, Grifols Diagnostic Solutions.
Management Representative for the San Diego site (reporting official) for the functions set out in ISO 13485: 2016 Creation and maintenance of Quality System processes, reporting on the effectiveness of the Quality System, of any need for improvement and promotion of knowledge of regulatory, compliance and customer requirements.
Management Representative for the San Diego site with the authority and responsibility for establishing and effective maintaining of Quality System according to 21CFR820 and reporting the performance of the Quality System to executive management.
Representative of the San Diego site to the FDA (CBER), FDA CDRH, EU Notified Bodies, Worldwide Health Authorities, certification agencies and customers for the inspections, official questions. Responsible for signing official letters or certificates representing the company on quality and compliance matters as well Safety Data Sheets.
The Director of Quality (Technical Director) is responsible for the safety, purity and efficacy of the products where GDSSD is the legal manufacturer and for ensuring the Quality of the NAT products
The Director of Quality (Technical Director) is responsible for assessing impact of changes to licensed products and ensuring all quality and regulatory requirements are met and for the regulatory strategy and approach to new products, new facilities and changes for FDA and CE mark.
Ensure that the New Products Development (NPD) process and the transfer of new products to Production are robust and take into account raw materials, production, transport, user handling, GST handling, use models and environment variations. The Director of Quality (Technical Director) will review and approve plans and reports for risk management, design inputs, design reviews and design inputs, design verification and validation and design outputs of the design process.
Director of Quality (Technical Director) guides, creates, facilitates, approves and authorise release of the core Regulatory Technical File and Regulatory responses to product questions. This is the set of documents needed by Global Regulatory for preparing the pre-submissions, submissions, periodic reports and official responses for the obtaining of the product licenses, change approvals and renovations in order to meet the registrations/authorizations plans.
Ensures, by reviewing and approving, that WW labelling is adequate for the intended use of the product and that meets all the laws and regulations. Ensures that only the specific country approved labelling is included in the product or web uploaded for each specific market and approve Promotional and Advertisement materials.
Ensure that internal communications (Technical Bulletins, letters, FSBs,..) are adequate.
Monitoring, review and take actions on the vigilance system and/or adverse events in any of its regulatory names (adverse event, incident CE, recall, withdrawal, FSN, FSCA, etc.) in all the territories where products are marketed. Authorize and sign the Customer Important Information Letters, Recalls, Field Safety Notices, BPD, MDRs for both reporting for the Authorities or Customer Communications.
Ensure establishment of appropriate division, departmental and individual metrics/quality objectives.
Ensure systems are in place (Design History Files, Device Master Records, Qualification and Validation activities) to adequately test and measure products against approved specifications and manufacturing limits.
Develop of a cohesive, effective team that works together to achieve defined and agreed upon service to internal and external customers.
Ensure effective and efficient systems are in place to appropriately measure and improve effectiveness of areas of responsibility.
Improve/modify existing complaint management system to minimize regulatory risk and maintain high customer satisfaction.
Ensure systems are in place to test product and measure against approved specifications and manufacturing limits.
Ensure systems are in place to monitor test results and evaluate for trends via paper or electronic (LIMS) systems.
Ensure systems are in place to only release product to customers that meet or exceed specifications.
Provide backup support to areas of responsibility when necessary.
Review and/or generate and approve corporate policies pertaining to the quality management system. Lead the organization QS and GMP training program.
Review Quality Management System, report findings, associated actions and opportunities for improvement to executive management.
Develop of a motivated, cohesive and effective team that works together inside area and with other areas to achieve defined objectives and agreed upon service to internal and external customers. Help establishing clear responsibilities between all areas within organization.
Work with other Grifols Management, decide on and oversee implementation of appropriate regulations and quality standards.
Key Performance Indicators / Measures for Success:
Successful Health Authority inspections
Continuous improved Product Quality
Compliance with Worldwide regulations and Grifols Quality Requirements
Fit with Grifols culture
Achievement of financial results
Advanced degree (MS/PhD) in Biological Sciences or related field or appropriate education and experience in Medical Device, IVD or biological/pharmaceutical manufacturing field
Fluent English (oral and written), fluency or working knowledge of Spanish is a plus
Minimum 15 years’ experience in biotechnology, blood banking, diagnostics, medical device or biopharmaceutical industries.
In depth knowledge of FDA, ex-USA and ISO regulation requirements as well as standard Quality management tools and standards.
Strong background experience in cGMP manufacturing, quality control, analytical methods/process/equipment validations are essential.
Minimum 10 years of managerial experience.
Able to initiate effective change in a dynamic and fast-paced environment.
Specific Professional Competencies:
Prior experience in mentoring, training, and providing positive and constructive feedback to staff and customers as needed.
Prior experience in leading a quality (QA, QC, NPD QA, QS/Compliance and Complaints) organization in an FDA regulated environment.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home