Manager Quality Assurance - Night Shift

The Manager Quality Assurance will work directly with plant manufacturing and engineering staff during the AR 30 startup and transition to on-going bulk drug substance manufacturing, including development, clinical, launch and commercial operations. The Manager Quality Assurance 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 includes partnership between Manufacturing, F&E and Quality staff providing coaching, guidance and direction in regards to deviations, quality systems and compliance.

The initial focus of this role will be on the AR 30 startup during Admin Day shift to prepare the new facility for Operational Readiness. After the facility startup phase, the successful incumbent will be expected to transition to a night-shift working schedule. The shift pattern will be Tuesday to Saturday, 3pm-12am. Reporting staff will work a 7pm-7am structure with a rotation covering 7 days per week.

Responsibilities:

• Oversee AR 30 startup activities for facilities, utilities, equipment, systems and processes with alignment and integration into the Amgen Quality Systems, including:
  • Interview candidates to build the AR 30 PQA team
  • Author/review/approve quality documents, such as: Standard Operating Procedures (SOPs), user requirements, risk assessments, training materials, engineering documents, automation documents, commissioning test protocols/reports, environmental qualification protocols/reports, validation protocols/reports
  • Oversee execution of, and change management related to, the following: factory acceptance, commissioning tests, facility qualifications and validation activities
  • Establish and enable LEAN practices
• Manage a team of PQA staff and perform managerial duties including: staff/team performance, and staff development
• Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations
• Ensure facilities, equipment, materials, organization, processes and procedures comply with cGMP practices and other applicable regulations
• 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
• Develop and communicate 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
• Review and approve operational and product manufacturing procedures, process validation protocols and reports for manufacturing processes, environmental characterization reports and change control documents.
• Approve deviations, representing Quality Assurance on project teams and approving change-over completion controls
• Oversee and provide guidance during on-the-floor analytical testing
• Lead and/or support audits, inspections and investigations

Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Quality or Manufacturing experience

OR

Bachelor's degree and 5 years of Quality or Manufacturing experience

OR

Associate's degree and 10 years of Quality or Manufacturing experience

OR

High school diploma / GED and 12 years of Quality or Manufacturing experience

AND

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

• Bachelor's Degree in Life Sciences or Engineering
• 6 + years of quality assurance or combination of quality and manufacturing experience in the biotechnology/pharmaceutical industry
• 3 + years of supervisory/management experience
• Experience in areas of manufacturing, investigations, corrective actions/preventative actions (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

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.