Product Quality Associate Director

What you will do

Amgens corporate Product Quality (PQ) team is seeking an enthusiastic, highly motivated, and team-oriented leader for the position of Product Quality Associate Director. Product Quality interfaces with International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on projects including support of product specifications, in-process controls, stability, periodic and annual product review, and complaint resolutions.

In this vital role you will be the single point of contact for Product Quality at the Amgen India Location (AIN) and lead a cross functional team of Product Quality staff to ensure staff support their respective Product Quality teams.

Such activities include product filings, program improvements, investigations, in-process controls, analytical methods, specifications, stability, reference standards, regulatory submissions and inspections.

The Product Quality team at AIN will support late-stage, commercial biologics and synthetics products. You will be directly responsible for management of staff and ensure team deliverables are met.

The team will provide project support to the relevant Product Quality Team (PQT) and respective Product Quality Leader (PQL) to implement and manage strategy for Quality to meet the Product Quality goals.

The team will be directly responsible for Product Quality related tasks including authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (document management system, complaint resolution system, data systems), and product data management, including stability, comparability assessments and periodic and annual product reviews. In addition, the team will be expected to play a role in supporting Product Quality initiatives intended to ensure the overall product health.

Roles & Responsibilities:

• Provide effective, cross-functional leadership of the PQ AIN team
• Support PQ deliverables for late-stage and/or commercial biologic or synthetic programs, including actions required for the PQT, APR, specifications, comparability, stability programs, and PQ owned regulatory filing sections and RTQs
• Support science and risk-based evaluation of complex process and product quality data such as in-process, release and stability data, complaints, method performance etc.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 3 years of Quality, Operations, Scientific, or Manufacturing experience, or
• Masters degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 6 years of Quality, Operations, Scientific, or Manufacturing experience, or
• Bachelors degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 8 years of Quality, Operations, Scientific, or Manufacturing experience and 3 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
• Demonstrate proficiency in oral and written communication of complex information to Product Quality team members and peers
• Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
• Strong scientific data management and organization skills with attention to detail
• Ability to deliver high quality results and adhere to project timelines using computer-based GMP Quality systems
• Ability to build and maintain cross-functional relationships and strong partnerships through written and verbal communication skills.

Preferred Qualifications:

• Experience working virtually on a cross-functional team in a matrix environment across multiple time zones
• Expertise in computer applications such as Veeva, Spotfire, SHINY
• Expertise in MS Office (Word, Excel, PowerPoint, MS Teams.

Soft Skills:

• Management, Analytical and problem-solving skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines
• Team-oriented, with a focus on achieving team goals
• Strong presentation and public speaking skills.