Sr. Manager Quality Assurance (QA)

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.

What you will do

Lets do this. Lets change the world. In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques and procedures. In this position you will monitor validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation.

This individual will supervise staff who actively participate during all phases of qualification/validation: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities.

Responsibilities

Supervise a diverse team of Quality Professionals which span multiple time zones. Review validation/qualification packages for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to managements attention and initiate and enforce necessary improvements and corrections to established systems and processes.

Participation and support of regulatory inspections. The following are examples of execution tasks for this position:

• Develop, Mentor, and oversee staff and day to day validation activities
• Act as reviewer and approver for operational SOPs and Work Instructions
• Review of operational SOPs and Work Instructions
• Review and approve change controls and Deviations/CAPA/CAPA EVs
• Initiate and own QA Deviations/CAPA/CAPA EVs as needed.
• Review and approve System Life Cycle Documents (i.e. test protocols) before use in production.
• Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
• Qualitative information
• Quantitative research
• Trend data
• Forecasts, models and applies advanced analytical tools
• Anticipates and prevents potential problems
• May be responsible for specific programs and/or projects
• Independently develops solutions that are thorough, practical and consistent with functional objectives
• Maintain budget
• Establish/Improve training curriculum
• Provide Management Review Updates on Quality activate
• Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
• Trend data
• Anticipate and prevent potential problems
• May be responsible for specific programs and/or projects
• Independently develop solutions that are thorough, practical and consistent with functional objectives

Basic Qualifications:

• Masters degree and 8 to 10 years of Software and Systems Quality assurance experience OR
• Bachelors degree and 10 to 14 years of Software and Systems Quality assurance experience OR
• Diploma and 14 to 18 years of Software and Systems Quality assurance experience .
• Experience owning and serving as QA Contact for Major and Minor Deviations
• Ability to interpret and apply GLPs, GCPs and GMPs
• Knowledge of industry and business principles
• Strong demonstration of problem-solving abilities
• Contributes to work group/team by ensuring quality of tasks/ services provided by self and others
• Provides training and guidance to others
• Extends capabilities by working closely with senior staff/ experts within and outside the internal organization.