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Product Quality Director - Synthetics

7+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Join Amgen’s Mission of Serving Patients
At Amgen, you're part of something bigger. Our mission—to serve patients living with serious illnesses—drives everything we do. Since 1980, we've been pioneers in biotech, focused on four key therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. Every year, we reach millions of patients. By joining the Amgen team, you’ll contribute to groundbreaking innovations that improve lives while also advancing your career.

Product Quality Director - Synthetics

What You Will Do
Let’s make an impact together. As a Product Quality Leader (PQL) at Amgen, you will provide strategic leadership, technical expertise, and project direction within the Product Quality (PQ) organization. The PQL works closely with teams across Amgen, including International Quality, Regulatory, Quality Control, and others, to resolve issues related to manufacturing, process controls, analytical methods, specifications, reference standards, investigations, and regulatory submissions. You will drive operational efficiency, corporate alignment, and manage product quality through its lifecycle.

This position involves overseeing the product quality for pivotal and/or commercial products, ensuring timely data review, ownership of GMP documents, regulatory filings, and providing leadership to the Product Quality Team (PQT). The PQL ensures quality standards for product stability programs, specifications, comparability, and site and method transfers.

You will:

  • Lead cross-functional quality efforts, managing long-term Product Development Team (PDT) deliverables.
  • Provide scientific oversight for comparability, specifications, stability programs, and regulatory filings.
  • Offer expertise in risk-based evaluation and contribute innovative solutions to complex issues.
  • Effectively communicate complex information to leadership, regulatory agencies, and cross-functional teams.
  • Mentor team members to foster core Product Quality skills.

What We Expect of You
The ideal candidate is a self-starter with a strong background in quality management, scientific expertise, and leadership. Here’s what we’re looking for:

Basic Qualifications:

  • Doctorate and 4+ years of experience in Quality, Operations, Scientific, or Manufacturing roles
  • OR a Master’s degree and 7+ years of experience in similar fields
  • OR a Bachelor’s degree and 9+ years of experience in similar fields

Preferred Qualifications:

  • Advanced degree in chemistry, biochemistry, biology, or related biotechnology field
  • Expertise in small molecule drug substance and product manufacturing, analytical testing, and industry regulations
  • 8+ years of experience in pharmaceutical quality, analytical development, or manufacturing
  • 6+ years in a regulated environment (GMP)
  • Leadership experience with a proven track record of managing teams, projects, and resources
  • Experience in writing and reviewing regulatory filings and supporting non-conformance investigations
  • Strong understanding of cGMP, analytical techniques, and the development of drugs and biologics
  • Excellent written and verbal communication, presentation, and facilitation skills

What You Can Expect of Us
At Amgen, we care for your professional and personal well-being. We offer a comprehensive benefits package, including health and welfare plans, financial benefits, and career development opportunities. You will also have access to:

  • Competitive salary and discretionary bonus programs
  • Stock-based long-term incentives
  • Generous time-off and flexible work models, including remote and hybrid options
  • A supportive and collaborative work environment

Apply Now
For a career that challenges and inspires, join us. Keyword: Product Quality Director - Synthetics.

Application Deadline:
Amgen does not have a fixed application deadline. We will continue accepting applications until the position is filled.