10.0 - 14.0 years

0 Lacs

hyderabad, telangana

On-site

The Quality Compliance Senior Manager plays a crucial role in the Clinical & Research Quality (CRQ) team for the R&D Quality Organization at Amgen. The CRQ team ensures that research and development activities are conducted ethically and responsibly, meeting the highest standards of quality and compliance to keep patients safe and protect their welfare. This position involves providing leadership to maintain excellence in R&D Quality Processes, mentoring Amgen staff in India, managing day-to-day activities, and ensuring compliance with regulations globally. Additionally, the Quality Compliance Senior Manager will support the digital quality management system (DQMS) and provide end-to-end quality support for managing Quality Incidents/Quality Events, including approving investigations and CAPA plans. Roles & Responsibilities: - Overseeing deviations, audits, and inspections across R&D Quality - Managing the Amgen India R&D Quality team - Facilitating deviation investigations and ensuring documentation within the electronic quality management system - Supporting Global Patient Safety and Global Development teams in inspection management activities - Leading continuous improvement initiatives for CAPA management practices - Collaborating with cross-functional partners to ensure effective processes aligned with industry best practices - Monitoring quality metrics, key performance indicators, and performing root cause trending - Maintaining knowledge of current regulatory and quality practices/issues - Managing archival and retention of audit documentation Basic Qualifications and Experience: - Masters degree with 10-12 years of Pharma and Biotech R&D or commercial manufacturing Quality experience - Continuous Improvement/Change Management experience preferred Additional Competencies/Skills: - Exceptional attention to detail and accuracy - Ability to work independently and proactively in a fast-paced environment - Proficiency in Smartsheet, Microsoft Office Suite, and virtual collaboration tools - Good team building skills and ability to develop employees over time - Familiarity with project management tools and methodologies - Knowledge of GCP, GLP, and/or GPvP - Experience working in a multinational environment - Excellent verbal and written communication skills - Strong problem-solving abilities and adaptability - Collaborative attitude and ability to build positive relationships across diverse teams Amgen ensures equal opportunities for individuals with disabilities throughout the job application process and employment. The company supports professional and personal growth through competitive benefits, a collaborative culture, and comprehensive Total Rewards Plans aligned with industry standards. Join Amgen to make a lasting impact on patient care and your career growth. Apply now at careers.amgen.com.,

Posted 4 days ago

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