Disposition Support Senior Manager

• The AIN QA Disposition Team Senior Manager will play a critical role in advancing Quality Assurance initiatives across the Amgen Network, with a particular focus on leading and directing a team of quality professionals responsible for the support of disposition supporting tasks.
• 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 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.
• As Senior Manager in the Quality Assurance organization, youre 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 Disposition Support 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

• Leadership of team responsible for execution of product expiration extension.
• Leading the team responsible to fulfill disposition related data requests made by Amgen partners
• Leadership of team responsible for Certificate of Authenticity generation
• Leadership of team responsible for providing dispositions systems-based training to new Quality staff across the Amgen network
• Leadership of team responsible for execution of product complaint related investigative tasks
• Leadership of team responsible for facilitation of global disposition network meeting and maintenance of network disposition metrics
• Coordination of AIN disposition support team to support Annual Product Review (APR) disposition support, data verification, and review/approval.
• Coordination of AIN disposition support team to support Amgen network audit and inspection data requests.

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

-Experience in the execution of product and/or raw material disposition release processes.

-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:

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