Director, Quality Assurance

Amgen • Holly Springs, NC

11h

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Requirements

• Bachelor's degree and 10 years of Quality/Manufacturing/Engineering experience OR Master's degree and 8 years of Quality/Manufacturing/Engineering experience OR Doctorate degree and 4 years of Quality/Manufacturing/Engineering experience
• At least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
• Managerial experience may run concurrently with the required technical experience referenced above

Nice To Haves

• Bachelor's Degree in a Science field
• 15+ years of experience in Quality within the biopharmaceutical or regulated manufacturing industry
• Previous experience in Quality oversight of Biologics drug substance operations
• Strong knowledge of cGMPs and experience interacting with Regulators
• Able to drive process improvement within area of responsibility
• Able to successfully manage workload to timelines
• Proven experience supporting regulatory inspections and site audits
• Demonstrated leadership of cross-functional teams within a manufacturing site
• Experience driving operational excellence and continuous improvement initiatives
• Excellent communication, leadership, and influencing skills

Responsibilities

• Accountable for leading the quality team supporting drug substance manufacturing execution activities within our site’s second FleX Batch manufacturing facility.
• Build and lead a high-performing quality organization responsible for supporting 24/7 manufacturing operations.
• Contribute to the development of the site Quality strategy leading teams accountable for all aspects of quality oversight of GMP systems and operations, while fostering a culture of execution excellence, accountability, and continuous improvement.
• Provide Quality input and expertise to support project and operational design decisions.
• Lead operational readiness activities to implement quality systems, programs, business processes and procedures.
• Track progress and communicate status.
• Lead and participate in Quality Risk Assessments.
• Build organization according to hiring strategy that supports project milestones.
• Recruit, coach, develop, motivate, and retain staff.
• Ensure ongoing organizational structure capable of adapting to evolving business needs.
• Drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies.
• Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties.
• Represent ANC Quality in cross-function and cross-site forums and in collaborations with Quality leaders across the Amgen network.
• 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.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Director