Associate Director - DTI Quality

Associate Director – DTI Quality


What you will do

Let’s do this. Let’s 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.

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 management’s attention and initiate and implement 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 SOP’s and Work Instructions

Review of operational SOP’s 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 activities

What we expect of you

The 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.


Basic Qualifications:

Doctorate degree and 3 years of quality experience OR,

Master’s degree and 10 to 14 years of quality experience OR,

Bachelor’s degree and 14 to 16 years of quality experience OR,

Diploma and 18 to 20 years of quality experience

4 years of managerial experience directly handling people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Knowledge of good documentation practices.

Proficiency in Microsoft (MS) Word, MS Excel, SharePoint, Documentum platform, and Microsoft Outlook email.

Ability to perform work that requires attention to detail, prioritization, and multitasking.

High degree of verbal and written comprehension for the English language.

Ability to work well with others and under time constraints, including the ability to prioritize workload.

Must grasp concepts quickly and react to changes rapidly.

Soft Skills:

Communication:Excellent verbal and written communication skills, with the ability to effectively collaborate with various departments and resolve discrepancies.

Organizational Skills:Strong ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines.

Adaptability:Ability to quickly grasp new concepts and react to changes in a constantly evolving environment.

Teamwork:Ability to work well with others and contribute to a positive team environment.

Problem-Solving:Strong analytical skills to identify and resolve issues related to documentation.

Customer Focus:Commitment to understanding and meeting the needs of internal and external key collaborators.

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, we’ll 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

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.