Quality Assurance Senior Manager, Plant QA

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but it will also integrate sustainability innovations to reduce carbon and waste as part of Amgens plan to be a carbon-neutral company by 2027.

Quality Assurance Senior Manager Plant QA

What you will do

Lets do this. Lets change the world. As a Quality Assurance Senior Manager you will lead our Drug Substance Plant QA (PQA) team and will serve as the Quality Leader for Good Manufacturing Practices (GMP) Operations within the Drug Substance Commercial Manufacturing facility. The QA Senior Manager PQA will play a key role in the Quality Assurance team focused on building a strong team and establishing efficient Plant Quality processes. The QA Senior Manager will lead a team of QA staff collaborate with cross-functional partners and provide QA leadership and oversight in support of the operational teams key responsibilities. Your team will work closely with the manufacturing team to assure product is produced according to quality standards and in alignment with the regulatory filing.

The QA Senior Manager will report to the Director of Quality Assurance for Drug Substance (DS) and be a member of the DS QA team that coordinates and contributes to serving Amgen patients via DS supply across all the Amgen commercial facilities. As a member of this leadership team and as a member of the cross functional leadership teams serving Drug Substance supply the QA Senior Manager will contribute to fostering and further developing the culture of Safety and Quality at ANC.

The job responsibilities will include but not be limited to:

• Staff Management - Leads a culture of safety and quality. Maintains the physical and psychological safety of self and others. Prioritizes professional development and drives continuous improvement mindset of direct reports. Performs staff recruitment and selection training oversight development and performance evaluations according to Amgens talent management program. Assures compliance with cGMP training requirements for staff.
• Quality Oversight - Ensures the Quality Management System processes are implemented and maintained in accordance with established procedures. Collaborate with the manufacturing team to ensure product is produced according to quality standards and in alignment with the regulatory filing. Provides direction and decision making for Quality system records and reports such as batch records investigations CAPAs Change Control. Reviews and approves records and reports. May serve as record or report owner. Own the realization of operational activities for PQA while providing technical expertise/guidance to the staff and ensuring Drug Substance is dispositioned in a timely manner; handle daily operations in relation to planning and management of the team and their tasks. Ensure that all operations follow applicable regulations and Amgen requirements relating to Good Manufacturing Practices Good Documentation Practices Safety and other controls.
• Quality Leadership - Collaborates cross functionally and across the Amgen Enterprise / Network to ensure the Quality Management System processes are implemented maintained performed and continuously improved in accordance with established procedures and applicable regulations. Lead and/or participate in audit and inspection activities to ensure compliance with commitments made to Regulatory Authorities and cGMPs. May provide leadership and perform additional duties within other areas of the Quality Management System including but not limited to: Management Review Change Review Board Risk Management. Alerts senior management of significant quality compliance supply and safety risks.
• Continuous Improvement - Serves as a team member with cross-functional colleagues on improvement initiatives regulatory inspection readiness activities and internal audits. Collaborates with cross functional staff and colleagues to achieve the objectives of the company in a safe and compliant manner. Engage in Amgens Operational Excellence program to develop stronger capabilities in continuous improvement.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The dynamic professional weseekis an employee with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Quality or Operations experience OR
• Associates degree and 10 years of Quality or Operations experience OR
• Bachelors degree and 8 years of Quality or Operations experience OR
• Masters degree and 6 years of Quality or Operations experience OR
• Doctorate degree and 2 years of Quality or Operations experience
• AND - In addition to meeting at least one of the above requirements you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• Educational background in Life Science or Engineering.
• Understanding of regulations standards and guidelines that apply to cGMP biotech manufacturing in a multi-product environment including familiarity of cell banking cell culture and protein purification operations.
• Experience with Quality Management Systems including Exceptions Change Control Risk Management and Product Disposition
• Strong experience working in a GMP environment.
• Familiarity with Computer / Automation systems (MES Delta-V PI data historian)
• Capability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant operations.
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.
• Experience participating in managing and responding to health authority inspections partner and corporate audits.
• Demonstrated leadership in multiple functional areas.
• Able to drive process improvement within area of responsibility.
• Familiarity with basic project management tools and lean
• Strong organizational skills including ability to follow assignments through to completion.
• Excellent written and verbal communication skills.

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

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 and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

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 disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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