Senior Director Quality Assurance

Role Summary

Senior Director, Quality Assurance responsible for leading Quality Operations at Amgen Rhode Island (ARI), overseeing two GMP manufacturing facilities, building and guiding a ~50-person team, and ensuring product quality and compliance with regulatory standards. Drive operational workstreams, integrate technology for tech transfer and compliant operations, and partner with site partners to deliver the mission of "Every patient, Every Time."

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 with 4+ years of Quality/Manufacturing/Engineering experience or Master’s degree with 8+ years of Quality/Manufacturing/Engineering experience or Bachelor’s degree with 10+ years of Quality/Manufacturing/Engineering experience.
• Required: At least 5 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing allocation of resources.
• Preferred: Bachelor’s Degree in a Life Science field.
• Preferred: 15+ years of pharmaceutical industry experience.
• Preferred: Prior experience in Quality oversight of Biologics drug substance operations.
• Preferred: Strong knowledge of cGMPs and experience interacting with Regulators.
• Preferred: Ability to drive process improvement within area of responsibility.
• Preferred: Ability to manage workload to timelines; strong leadership and communication skills.

Education

• Bachelor’s Degree in a Life Science field (preferred).