Head QA

Kashiv BioSciences, LLC

15 - 19 years

0 Lacs

ahmedabad gujarat

Posted:1 day ago| Platform: Shine logo

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Skills Required

quality assurance compliance quality systems cgmp quality control document control clinical trials quality operations product quality operational efficiency supervision performance management recruitment employee development promotions process improvement initiatives technical liaison compliance capa complaint management travel regulatory adherence quality assurance departments training systems regulatory expertise qualification validation processes bla submissions crossfunctional teams corrective preventive actions capas continuous improvement initiatives vendor management collaboration continuous improvement programs regulatory inspections salary increases global collaboration culture of compliance quality management systems quality responses business development proposals training activities regulatory knowledge

Work Mode

On-site

Job Type

Full Time

Job Description

As the Head of Quality Assurance and Compliance at our Biopharmaceutical company, your role will be crucial in maintaining the highest standards of quality, compliance, and regulatory adherence. Reporting directly to the executive leadership team, you will play a critical role in upholding and enhancing our reputation for excellence in the industry. **Role Overview:** You will be responsible for establishing and maintaining robust Quality Systems to support cGMP activities, ensuring compliance with regulatory requirements and industry standards. Your role will involve managing the Quality Control and Quality Assurance departments, overseeing document control and training systems, and leading quality operations activities for product disposition. **Key Responsibilities:** - Develop and maintain Quality Systems to support cGMP activities - Direct and oversee Quality Control and Quality Assurance departments - Provide oversight of document control and training systems management - Demonstrate expertise in cGMP, Quality Systems, and regulatory guidance - Lead Quality Operations activities for product disposition - Supervise QA and QC Managers - Prepare for and manage regulatory agency inspections - Recruit, develop, and retain quality personnel - Establish a culture of compliance and continuous improvement - Drive continuous improvement initiatives - Lead cross-functional teams to resolve quality issues - Collaborate with Vendor Management for vendor quality requirements - Provide formal and informal performance feedback to direct and indirect reports - Ensure compliance with all company policies and standards - Plan and direct resources and activities of quality and compliance functions globally - Lead Quality responses for information requests and business development proposals - Ensure technical liaison and training activities related to quality and compliance - Maintain knowledge of FDA, EU, MHRA, & EMA regulations and standards - Maintain robust CAPA, nonconformance, and complaint management systems - Travel up to 10%, including international travel, and perform other duties as assigned **Qualifications Required:** - Bachelor's degree in pharmacy, biology, chemistry, or a related field; advanced degree preferred - Certification in quality management preferred - 15+ years of experience in quality assurance leadership roles within the biopharmaceutical industry - In-depth knowledge of biopharmaceutical manufacturing processes - Strong understanding of regulatory requirements governing biopharmaceutical manufacturing - Excellent leadership, communication, and interpersonal skills - Demonstrated experience in leading and managing teams - Highly organized, detail-oriented, and analytical Apply now and join us in maintaining the highest standards of quality, compliance, and regulatory adherence in the biopharmaceutical industry!,

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Head QA