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Job Details
Alcura is a Cencora-owned company specializing in clinical trial logistics management and healthcare services. They offer customized solutions for pharmaceutical companies, healthcare providers, and patients, including clinical trial management and patient support services.
As the Quality Assurance and GDP Manager for Alcura you will lead a dedicated team responsible for overseeing the distribution of medication for clinical trials. This role ensures compliance with all regulatory requirements, implement and maintain quality management systems, and drive continuous improvement initiatives across the organization. Your leadership will be pivotal in fostering a culture of quality, safety, and operational excellence.
FUNCTIONS:
Development and Implementation of Quality Strategies:
Design and execute quality assurance and good distribution practice strategies that align with Alcura's business objectives.
Implementing and defining the quality management system based on ISO 9001, ISO 13487, GMP, and GDP.
Strategic definition of the quality mission, view, and goals.
Leadership in Regulatory Compliance: Ensure that all operations comply with local and international regulations regarding the quality and distribution of pharmaceutical products.
Risk Management: Identify and assess potential risks in quality and distribution processes, implementing effective mitigation measures.
Oversight of Audits and Assessments: Coordinate and oversee internal and external audits, ensuring that a high standard of quality is maintained across all operations.
Staff Development and Training: Provide leadership and training to the QA and GDP team, promoting professional development and understanding of industry best practices.
Data Analysis and Reporting: Analyze quality and distribution data, generating regular reports for senior management on the performance of the quality system and areas for improvement.
Management of Strategic Projects: Lead strategic projects related to quality and distribution, ensuring alignment with organizational goals.
Managing and coordinating internal audits to establish continuous improvement actions.
Review and approve QA agreements, quality questionnaires, TA (Technical Agreements).
Coordinating tasks of Quality Assurance and GDP staff.
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REQUIREMENTS:
University Degree in Sciences: A bachelor's degree in a relevant scientific discipline is required.
in-depth Knowledge of GMP/GDP: Extensive knowledge of Good Manufacturing Practices (GMP) and Good
Distribution Practices (GDP) is essential.
Comprehensive Understanding of Quality Systems: Strong familiarity with quality management systems, including relevant training, is necessary.
Advanced Proficiency in English: Must possess advanced English language skills, both written and verbal.
What Cencora offers
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Full timeAffiliated Companies
Affiliated Companies: Alcura Health España S.A.Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
