Product Quality Associate Director

About the role

Amgen’s corporate Product Quality team is seeking an enthusiastic, highly motivated, and team-oriented leader for the position of Product Quality Associate Director. As Product Quality Associate Director, you will provide technical expertise and leadership within a Product Quality Team, engaging with Product Quality, International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on a variety of activities such as product filings, program improvements, and investigations associated with product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections.

Responsibilities

• Ensures Product Quality deliverables are appropriately defined within timelines across the Product Delivery Team; deliverables are clear with priorities set based on program guidance.
• Coordinates discussion and leads decision making for strategies and activities supported within the Product Quality Team (Quality Assurance, Stability, Process Development, and other functions as needed) for programs they support.
• Accomplishes results by leading activities across the product quality team and with cross-functional SMEs for programs they support.
• Provide effective, cross-functional Quality leadership, and influence and support program deliverables for late phase and commercial programs, including actions required for the annual product reviews, specifications, comparability, and stability programs; site and method transfers; product quality impact assessments; and author PQ-owned regulatory filing sections and RTQs.
• Provide subject matter expertise and strategic influence for science and risk-based evaluation of complex process and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues.

Requirements

• Doctorate degree and 3 years of Quality, Operations, Scientific, or Manufacturing experience
• OR Master’s degree and 5 years of Quality, Operations, Scientific, or Manufacturing experience
• OR Bachelor’s degree and 7 years of Quality, Operations, Scientific, or Manufacturing experience
• OR Associate’s degree and 12 years of Quality, Operations, Scientific, or Manufacturing experience
• OR High school diploma / GED and 14 years of Quality, Operations, Scientific, or Manufacturing experience

Qualifications

• B.S. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
• 6+ years working in a regulated environment (either direct GMP or technical support) with experience working with biologic products.
• 1+ year experience with authoring or review of market applications, IND, supplements or similar regulatory documentation.

Skills

• Must-Have Skills:
  • Demonstrate proficiency in oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies.
  • Demonstrate proficiency in knowledge of cGMP and international regulatory expectations.
  • Strong scientific data management and organization skills with attention to detail.
• Soft Skills:
  • 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.