Sant Cugat Del Valles Compliance Assurance Manager

Job description

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. We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding. Help us lead one of the world’s largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20,000 people. That’s why we need an ASSURANCE, INVESTIGATIONS & CAPA MANAGER like you. Mission Manage the global Compliance Assurance, Investigations & CAPA services within Corporate Compliance by: - Establishing and overseeing a consistent framework for compliance risks, controls, assurance, investigations, and corrective and preventive actions across programs in scope. - Providing independent oversight and assurance over the design, implementation, and operating effectiveness of compliance controls, and ensuring the timely identification, investigation, remediation, and escalation of significant compliance deviations and risks. - Promoting best practices, governance, and continuous improvement across compliance programs, strengthening the control environment, mitigating compliance risks, and fostering a culture of accountability and compliance. What are your responsibilities: COMPLIANCE ASSURANCE & MONITORING 1. Act as the functional expert for compliance assurance methodologies, standards, and best practices. 2. Consolidate compliance risks and controls across programs in scope into a consistent control framework. 3. Maintain and periodically update the compliance risk and controls matrix. 4. Design and coordinate compliance assurance reviews and testing programs. 5. Assess the design and operating effectiveness of key compliance controls. 6. Support Compliance Officers in risk assessments, maturity assessments, and program self-assessments. 7. Monitor remediation of assurance findings and evaluate the effectiveness of corrective actions. 8. Coordinate with Internal Audit, Internal Controls, ERM, Quality, and other assurance functions to ensure alignment and avoid duplication. 9. Provide periodic reporting on assurance activities, control effectiveness, and emerging control weaknesses. 10. Monitor trends, recurring issues, and emerging compliance risks across programs. 11. Oversee exception management and monitoring activities across programs in scope. 12. Define and maintain the corporate compliance controls framework and assurance approach across programs in scope. 13. Develop and maintain risk-based assurance plans across programs in scope. DEVIATIONS & INVESTIGATIONS MANAGEMENT 1. Act as the functional expert for investigations, deviation management, and related methodologies. 2. Design, coordinate, and supervise internal investigations mandated by Compliance Officers. 3. Establish and maintain investigation protocols, standards, and documentation requirements. 4. Manage the intake, triage, classification, and tracking of compliance deviations and allegations. 5. Conduct root-cause analyses of identified compliance failures and control breakdowns. 6. Monitor trends in deviations, investigations, and recurring compliance issues. 7. Identify systemic weaknesses and recommend actions to prevent recurrence. 8. Provide periodic reporting on investigation outcomes, deviation trends, and key lessons learned. 9. Promote best practices regarding investigation quality, consistency, confidentiality, and documentation. 10. Escalate significant deviations, investigation outcomes, and systemic control weaknesses to Compliance leadership as appropriate. CAPA & CONTINUOUS IMPROVEMENT 1. Own the global CAPA framework, methodology, and governance process. 2. Manage the lifecycle of corrective and preventive actions arising from assurance reviews, investigations, monitoring activities, and risk assessments. 3. Ensure CAPAs are appropriately designed, assigned, implemented, documented, and validated. 4. Challenge action owners to ensure remediation addresses root causes rather than symptoms. 5. Monitor CAPA implementation and verify effectiveness prior to closure. 6. Escalate overdue, ineffective, or high-risk CAPAs to Compliance leadership. 7. Analyze CAPA trends and recurring findings to identify opportunities for process improvement. 8. Drive continuous improvement initiatives to strengthen compliance processes and controls. 9. Report CAPA status, aging, effectiveness, and key remediation metrics to management. 10. Prepare and present assurance, deviations, investigations and CAPA metrics to Compliance leadership and governance committees Who you are To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions). Required: • Degree in Business Administration, Finance, Engineering or related field. • 5+ years of experience: compliance assurance, internal controls, investigations, internal audit, quality assurance and risk management. • Strong interpersonal skills, with a balanced degree of autonomy, leadership and teamwork. • Strong confidence, with a well-balanced degree of assertiveness and flexibility. • Compelling ability to say “no” when company values and/or compliance with laws or company policies could be at risk, even to high-ranking officers. • Excellent writing and communication skills, both in Spanish and English, with enough proficiency to target all staff levels. • Familiarity with international compliance rules and regulations • Familiarity with the healthcare industry globally. • Good ability to analyze and understand complex business proposals. • Sound judgment and intellect combined with a pragmatic, business solution-oriented approach. • Strong image and presence with ability to interact with, and provide confidence and guidance to different staff levels. • Proficient in providing advice to senior management on ethical and compliance implications of business decisions. • Expected to act honestly, independently, impartially and with discretion. What we offer It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment. Information about Grifols is available at www.grifols.com. If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply! We look forward to receiving your application! We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help. Grifols is an equal opportunity employer. Flexibility for U Program: Hybrid Model Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time). Benefits package Contract of Employment: Permanent position #LI-ER1 #LI-Hybrid Location: SPAIN : España : Sant Cugat del Valles Learn more about Grifols Enviar candidatura ahora » Buscar ofertas de trabajo similares: ESPANA, all_jobs, ALLJOBS/, ALLJOBS • Grifols • LinkedIn • AVISO DE PROTECCION