Senior Manager Quality Assurance, Technical Resources

The AIN QA Technical Resource Team Senior Manager will play a critical role in advancing Quality Assurance initiatives across the Quality Operations Network, with a particular focus on leading and directing a team of quality professionals responsible for the support of Management Review, Inspections and Compliance, and Technical Writing & Data Analytics. 

The senior manager will use strategic planning and prioritization to support the collective requirements of the Quality organization alongside the individual needs and timelines of the sites. 

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

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 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.

As Senior Manager in the Quality Assurance 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 Quality Assurance operations:

Focus Areas

• This role provides operational support, technical leadership, and cross-functional collaboration to ensure compliance, continuous improvement, and data-driven decision making in support of the Quality Management System (QMS).
• Oversight of the AIN-based Quality Assurance Technical Resource team
• Collaboration with the global quality leaders and business process owner(s) to resolve issues encountered by the team
• Management of request prioritization in alignment with QA network needs
• 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 Amgen network across multiple time zones

The following are some examples of tasks for the position

• Support of management review (MR) at each Amgen site through collaboration with Amgen leadership and coordination of the AIN technical support team to provide MR (management review) logistical support, metrics/KPI’s, meeting agenda/content, site-level and cross-site trend analysis, and meeting facilitation.    
• Leading the team responsible to provide readiness and response for internal and external inspections, including generation of pre-inspection documents such as deviation lists, change controls, and supporting evidence.
• Actively contribute during inspections by managing team to provide timely response to information requests, facilitating document electronic retrieval, and preparing responses in collaboration with subject matter experts.
• Leading a technical writing and data analytics workstream that includes responsibility for periodic quality trend report authorship, Site Master File authoring, product and process monitoring deviation summary reports, and leading quality risk management processes.

Preferred Qualifications

-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

-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

-Experience with various Quality Systems and applications

-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

Basic Qualifications and Experience:

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