Senior Manager Quality Control

Role Description:

In this vital role, you will lead the Amgen India, Quality Control Technical Resources Team. This is a unique opportunity to support the global Quality Control network and to learn about the testing of Amgen products through various stages of the product lifecycle. In addition, as this is a newly formed team, the Senior Manager will have the opportunity to develop new business processes and to strategically develop the team structure.

The QC Technical Resources team will primarily provide centralized document management support for the global QC Network. This will include the creation and/or revision of controlled documents within Amgens enterprise document management system for a variety of QC processes. The Senior Manager Quality Control will provide management oversight of this team while fostering a culture of innovation, quality and collaboration. The Senior Manager will report directly to Amgen India Quality Leadership.

This candidate will primarily work during regular working hours (9 AM 6 PM local time) to enable the business in delivering Amgens mission to serve patients and may 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.

Roles & Responsibilities:

• The Senior Manager Quality Control will be accountable for the following activities:
• Daily management of the Quality Control Technical Resources team
• Responsible for organizing team resources to ensure that agreed upon due dates are met for QC Network requests
• Responsible for creating and maintaining business processes and tools that will facilitate the management and visibility of QC network requests
• Responsible for ensuring that the Technical Resources team has access to the required laboratory information management and enterprise systems needed to carry out document management tasks (for example, LIMS, electronic laboratory notebook).
• Responsible for leading issue resolution and problem-solving exercises within the team and cross-functionally, as needed
• Support staff training, career development and performance management
• Responsible for ensuring compliance with safety guidelines, cGMPs and other applicable regulatory requirements.

Additional Responsibilities:

• Participate in Amgen global network teams
• Establish and enable LEAN principles across area of responsibility
• Establish and enable department goals, strategies and KPIs
• Champion site and QC global process improvements
• Interfaces with management on significant matters, often requiring the coordination of activity across organizational units
• Plans and organizes project assignments of substantial variety and complexity
• Translates complex data into actionable information and applies strong technical knowledge to meet business objectives
• Identifies process gaps, introduces innovative solutions, and leads operational excellence projects to improve efficiency and productivity, while decreasing expense/operating costs.
• Leads root cause analysis discussions for more complex problems to develop and efficiently implement effective permanent solutions.

Basic Qualifications and Experience:

• Masters degree with 12-16 years of Pharma and Biotech commercial or clinical manufacturing Quality Control experience

AND

• 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Functional Skills:

Must-Have Skills:

• Experience working and leading teams in a cGMP laboratory environment.
• Strong technical writing skills within a highly regulated environment.
• Working knowledge of cGMP regulations, practices, and trends pertaining to Quality Control.
• Experience managing staff and/or leading teams, projects, programs or directing the allocation of resources.

Good-to-Have Skills:

• Track record of building or participating as a member of high performing team.
• Experience with various laboratory computer systems and applications.
• Strong leadership and negotiation skills with a demonstrated ability to influence different styles.
• Demonstrated innovative thinking and ability to transform work organizations.
• Exposure to Operational Excellence initiatives.
• Understanding of quality management systems and quality control processes related to drug substance and drug product for clinical and commercial operations.
• Demonstrated ability to navigate through ambiguity and provide structured problem solving.
• Demonstrated ability to coordinate multi-functional project teams and deliver on schedule.
• Demonstrated ability to coordinate and lead cross-functional teams.
• Demonstrated ability to find opportunities and implement new technologies and services to transform the business into a more agile, efficient and effective organization.
• Demonstrated skills in staff motivation, coaching/mentoring and professional development.
• Great teammate who can collaborate and provide leadership through influence to achieve the required results.