Amgen

Career Category

Quality

Job Description

QC Systems Templating Senior Manager

Role Name: QC Systems Templating Senior Manager

Department Name: Quality Control

Role GCF: 6

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role Description:

Let’s change the world. In this vital role you will lead the team responsible for creation and management of master data templates for QC systems, including ELN (electronic laboratory notebook) and the consumable inventory system, used globally across the Amgen QC network. You will use strategic planning and prioritization to support the collective requirements of the QC organization alongside the individual needs and timelines of the sites.

This candidate will primarily work during regular working hours (9 am – 6 PM local time) to enable the business in delivering Amgen’s mission to serve patients and will lead a shift-based team that provides coverage in support of the Amgen network across multiple time zones. The candidate may need to work outside of his/her routine workday to support business needs and will be responsible for determining the same for their staff. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN).

The candidate will also lead the remote support from AIN to Amgen sites across multiple time zones globally.

As Senior Manager in the Quality Control organization, you’re in a leadership position with responsibilities to supervise and mentor staff. As a leader, you will focus your efforts on the following functions in support of global QC systems operations:

Roles & Responsibilities:

• Oversight of the AIN-based QC Systems team in support of QC system master data creation, management and qualification
• Collaboration with the global business process owner(s) to resolve issues encountered by the team
• Management of request prioritization in alignment with QC network needs
• Maintaining alignment between sites on use of QC systems and driving further standardization of testing documentation
• Collaboration with other global and site-based QC teams to achieve QC network goals
• Support staff training, career development and performance management of team across all three shifts
• Responsible for ensuring compliance with safety guidelines, cGMPs and other applicable regulatory requirements
• Champion process improvements to increase efficiency and productivity
• Assign workload appropriately and strategically based on required interactions with sites in the QC network across multiple time zones

The following are some examples of tasks for the position

• Evaluate master data requests and categorize based on complexity
• Assign requests taking into consideration priority, network alignment and requested completion timelines
• Track progress of requests in alignment with due dates, and course correct as necessary
• Escalate roadblocks faced by the team to avoid impact to achieving targets
• Apply analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
• Anticipate and prevent potential problems with engagement in the network of knowledge sharing in near misses
• Provide updates to the global QC network on metrics, analyzing data and recommending improvements

Basic Qualifications and Experience:

Master’s degree with 12-16 years of Pharma and Biotech commercial or clinical manufacturing Quality Control experience.

In addition to meeting the above requirement, you must have a minimum of 5-7 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.

Functional Skills:

• Strong project management skills and experience supervising professionals in a Quality organization working with cross functional and global stakeholders across multiple time zones
• Working knowledge of cGMP regulations, practices, and trends pertaining to Quality Control
• Experience with various laboratory computer systems, equipment/instrumentation, and applications

Soft Skills:

• Excellent written and verbal communication skills, ability to work in a team environment and build relationships with partners
• Track record of building and maintaining a high performing team
• Strong leadership and negotiation skills with a demonstrated ability to influence others
• Demonstrated innovative thinking and ability to transform work organizations
• Demonstrated ability to navigate through ambiguity and provide structured problem solving
• Demonstrated ability to deliver right the first time on schedule in accordance with established Service Level Agreements
• Demonstrated skills in staff motivation, coaching/mentoring and professional development

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with 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 an accommodation.

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