Manager QA

Amgen • West Greenwich, RI

19h • $118,235 - $159,965 • Onsite

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. In this vital role you will hire, train, develop, and manage Quality Assurance professionals to successfully deliver on role to support GMP Manufacturing and to manage change in an effective, efficient and compliant manner. This individual will be responsible for overseeing our Day shift Plant Quality Assurance teams, who work 7am-7pm.

Requirements

• High school diploma / GED and 12 years of Quality experience OR Associate’s degree and 10 years of Quality experience OR Bachelor’s degree or and 5 years of Quality experience OR Master’s degree and 3 years of Quality experience OR Doctorate degree
• Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Nice To Haves

• Bachelor’s Degree in Life Sciences, Engineering or related field
• 6+ years of quality assurance or combination of quality and manufacturing experience in the biotechnology/pharmaceutical industry
• 2+ years of supervisory/management experience
• Experience in areas of manufacturing, investigations, CAPA, product release, validation and/or change control
• Experience in regulations, standards and guidelines that apply to biotech manufacturing in a multi-product environment
• Ability to develop meaningful team and staff goals, manage performance and coach and develop staff
• Ability to manage to established timelines and deliver results to meet or exceed department and company goals and objectives.
• Thorough knowledge of monoclonal antibody manufacturing or ability to apply previous biotech manufacturing knowledge to understand manufacturing deviations
• Ability to communicate clearly, facilitate discussions and present to audiences at all levels of a site organization
• Decisive and independent risk-based decision-making ability on the floor to support manufacturing needs
• Ability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant manufacturing

Responsibilities

• Independently determine approach to managing daily operations; guided by general policies and management guidance
• Develop or contribute to the development of procedures and standards by which others will operate.
• Interpret and execute standards and procedures directly affecting work activities
• Develops and communicates goals and objectives to staff and key partners
• Monitor goal performance and coordinate action for improvement of shift and overall PQA performance by championing department OPEX efforts.
• Assist project teams in establishing priorities, project timelines and in securing resources.
• Actively represent Quality Assurance on incident triage teams or support efforts by providing guidance and/or technical leadership
• Partner with internal personnel at various management levels to resolve issues, establish direction, obtain resources, and drive change
• Reviewing and approving operational procedures and product manufacturing procedures, approving process validation protocols and reports for manufacturing processes, and approving environmental characterization reports and change control documents.
• Approving non-conformances, representing QA on project teams and approving change-over completion controls.
• Leading investigations, as well as leading plant and site audits.

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: Manager
• Education Level: High school or GED