Pharmaceutical Change Control Manager
Grifols
Lead pharmaceutical change controls at Grifols, applying quality management and regulatory impact assessment across processes, systems, and technologies.Reporting to the Corporate Quality Director, this manager supervises technical change control activities affecting product and Blood Establishment licenses. The work coordinates Manufacturing, Quality, and Regulatory Affairs stakeholders while evaluating implementation requirements. You will develop study protocols, assess generated data, and guide Quality specialists.Key Responsibilities:
Establish processes to approve or reject proposed changesCoordinate requests and identify areas requiring evaluationEvaluate regulatory impacts on product and establishment licensesDevelop protocols, acceptance criteria, and monitoring requirementsVerify implementation alignment and assess generated dataRequirements:
Bachelor’s degree in health-related sciencesPostgraduate certification in quality managementSix years’ related pharmaceutical change control experienceFour years’ management or technical leadership experienceKnowledge of cGMP requirements and MS OfficeBring regulated pharmaceutical change control leadership, protocol development, and compliance expertise to Grifols’ quality organization.
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Establish processes to approve or reject proposed changesCoordinate requests and identify areas requiring evaluationEvaluate regulatory impacts on product and establishment licensesDevelop protocols, acceptance criteria, and monitoring requirementsVerify implementation alignment and assess generated dataRequirements:
Bachelor’s degree in health-related sciencesPostgraduate certification in quality managementSix years’ related pharmaceutical change control experienceFour years’ management or technical leadership experienceKnowledge of cGMP requirements and MS OfficeBring regulated pharmaceutical change control leadership, protocol development, and compliance expertise to Grifols’ quality organization.
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Vacancy posted 1 hour ago
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