QA Manager - Holly Springs, NC

Let’s do this! Let’s change the world!

In this dynamic role you will be the Manager Quality Assurance for the PQA team and will work directly with plant manufacturing and engineering staff during the Amgen North Carolina (ANC) facility 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 (Good Manufacturing Practices) GMP Manufacturing and to oversee and manage change in an effective, efficient and compliant manner. This includes partnership with Manufacturing, Facilities & Engineering and other support functions providing coaching, guidance and direction in regards to deviations, quality systems and compliance aspects.

The initial focus of this role will be on the ANC startup to prepare the new facility for Operational Readiness.

Candidate will be working on site. After the facility startup phase, the successful incumbent will be expected to transition to a shift working schedule, to include late afternoon and nights.

• Oversee ANC startup activities for facilities, utilities, equipment, systems and processes with alignment and integration into the Amgen Quality Systems, including: Interview candidates to build the ANC PQA team, Author/review/approve quality documents, related to: Standard Operating Procedures (SOPs), user requirements, risk assessments, training materials, engineering documents, automation documents, commissioning test protocols/reports, environmental & utility 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.

• Manage a team of PQA staff and their daily operations (verify training, schedules, ongoing tasks, prioritization and support needed)

• Oversee staff/team performance

• Prioritize and support 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

• Participate in Inspection Readiness program activities to ensure facilities, equipment, materials, organization, processes and procedures comply with cGMP practices and other applicable regulations

• 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 team and overall Plant

• Quality Assurance (PQA) performance by championing department operational excellence and Lean 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.

• Support site audits and inspections.