Senior Quality Assurance Manager Aurora
Piramal-Pharma-Solutions
Lead quality assurance, QMS, and regulatory affairs at Piramal Pharma Solutions’ Aurora site, overseeing compliance, risk, and quality decisions. This senior leadership role directs teams and priorities across site functions.The Senior Manager provides leadership for QA, Quality Management Systems, and Regulatory Affairs. You will oversee cGMP compliance, quality events, investigations, batch disposition, regulatory commitments, and inspection readiness. The role partners with Operations, Analytical Services, R&D, Engineering, and Supply Chain.Key Responsibilities:
Set objectives, resource priorities, and performance expectationsOversee quality events, investigations, remediation, and escalationApprove or reject APIs, intermediates, and productsReview QMS metrics, trends, risks, and improvementsLead inspection and client audit readinessRequirements:
Leadership across QA, QMS, and Regulatory AffairsKnowledge of applicable cGMP requirements and regulatory commitmentsExperience directing quality decision-making and escalationAbility to develop employees and technical capabilityAbility to manage resources and departmental budgetsUse senior QA, QMS, and regulatory leadership to strengthen compliance, risk management, and quality performance at Aurora.
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Set objectives, resource priorities, and performance expectationsOversee quality events, investigations, remediation, and escalationApprove or reject APIs, intermediates, and productsReview QMS metrics, trends, risks, and improvementsLead inspection and client audit readinessRequirements:
Leadership across QA, QMS, and Regulatory AffairsKnowledge of applicable cGMP requirements and regulatory commitmentsExperience directing quality decision-making and escalationAbility to develop employees and technical capabilityAbility to manage resources and departmental budgetsUse senior QA, QMS, and regulatory leadership to strengthen compliance, risk management, and quality performance at Aurora.
#J-18808-Ljbffr
Vacancy posted 1 hour ago
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