Senior Director Quality Assurance

Role Summary

Senior Director, Quality Assurance. Join Amgen’s mission to serve patients living with serious illnesses. Drive Quality Operations at a state-of-the-art Drug Substance manufacturing site, lead a team of about 50 associates, and ensure product quality standards are met in compliance with cGMP and regulatory requirements.

Responsibilities

• Lead Plant QA team providing Quality Oversight of 24/7 continuous manufacturing operation and high impact strategic decision making in two multi-product Drug Substance facilities (14 products) with accelerated run rate and expansion projects to support volume driven growth and innovative pipeline.
• Scope includes on-the-floor support for AR5 Fed batch and AR30 MoF, I-530, Buffer Preparation Area, Media Preparation, Component Preparation Area, In Process Testing Lab, record review, quality oversight of deviation investigations and changes, document approval, and disposition.
• Ensure drug substance is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Amgen standards, and other applicable regulations and specifications.
• Provide oversight to ensure that Amgen Quality Management System is implemented and maintained in accordance with corporate standards.
• Track performance and drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies.
• Provide quality input and partner with cross-site and cross-functional area leads to advance Amgen’s manufacturing strategy.
• Develop strategies in support of regulatory inspections and site audits.
• Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties.
• Develop area budget, manage expenditure and identify productivity improvement opportunities.
• Represent ARI Quality in cross-function and cross-site forums.
• Provide Quality input to support project or operational design decisions.
• Alert management of significant quality, compliance, supply, and safety risks.
• Communicate across all levels of the organization. Facilitate development of solutions to critical business issues.

Qualifications

• Required: Doctorate degree and 4 years of Quality/Manufacturing/Engineering experience OR
• Required: Master’s degree and 8 years of Quality/Manufacturing/Engineering experience OR
• Required: Bachelor’s degree and 10 years of Quality/Manufacturing/Engineering experience
• At least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Preferred Qualifications

• Preferred: Bachelor’s Degree in a Life Science field
• Preferred: 15+ years’ pharmaceutical industry experience
• Preferred: Previous experience in Quality oversight of Biologics drug substance operations
• Preferred: Strong knowledge of cGMPs and experience interacting with Regulators
• Preferred: Able to drive process improvement within area of responsibility
• Preferred: Able to successfully manage workload to timelines
• Preferred: Leadership and communication skills

Education

• Bachelor’s Degree in a Life Science field
• Advanced degree in related field (as applicable)