Manager Quality Assurance - PQA

Career Category

Quality

Job Description

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

MANAGER QUALITY ASSURANCE – PQA

What you will do

Let’s do this. Let’s change the world. In this vital 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.

* Staff for the PQA team are on-site workers.

The Plant Quality Assurance team will work different shift structures to provide ongoing support to our functional teams and 24/7 operations. After the facility startup phase, the successful incumbent will be expected to transition to a shift working schedule, including weekends, and is intended to serve 1st shift hours (very early morning through mid-afternoon). Specific hours will be determined based on operational needs.

• 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications.

Basic Qualifications:

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