Product Quality Director

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead a product team as the Product Quality Leader, delivering technical expertise, strategic guidance, and project management to the Product Quality organization.

• Collaborate with Product Quality personnel and executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory, Process Development, Quality Assurance, and other functional areas to address product and process quality challenges.

• Direct product quality initiatives related to comparability, specifications, stability, and annual product reviews in support of the Product Development Team.

• Provide scientific oversight for pivotal and/or commercial products.

• Review product data and manage GMP documents and sections of regulatory filings.

• Execute transactions in relevant GMP systems, such as EDMQ and change control.

• Assist in regulatory audits and respond to inquiries.

• Lead a Product Quality Team, including oversight of product stability programs.

• Offer indirect management and guidance to members of the Product Quality Team.

• Provide cross-functional quality leadership and handle complex, long-term deliverables for the Product Development Team.

• Oversee programs related to specifications, comparability, stability, site transfers, and method transfers.

• Create product quality impact statements for non-conformances and sections of regulatory filings owned by Product Quality, along with responses to technical inquiries.

• Analyze complex process and product quality data using scientific and risk-based methodologies.

• Develop patient-focused strategies and innovative solutions for complex issues.

• Effectively communicate intricate information to leadership, peers, and regulatory agencies, including during inspections.

• Keep abreast of emerging scientific and technical trends and their impacts on Amgen.

• Mentor both new and existing team members in essential Product Quality skills.

⛳️ Requirements

• Doctorate degree and 4 years of experience in Quality, Operations, Scientific, or Manufacturing OR a Master’s degree and 7 years of experience in the same areas OR a Bachelor’s degree and 9 years of experience in Quality, Operations, Scientific, or Manufacturing.

• Advanced degree in chemistry, biochemistry, biology, or a related field within biotechnology sciences.

• Proficiency in protein and small molecule analysis along with industry regulations.

• 8+ years of pharmaceutical experience with increasing responsibility in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing settings.

• 6+ years of experience in a regulated environment (direct GMP).

• 5+ years of experience managing staff with escalating responsibilities and larger teams.

• 2+ years of experience as a PQL, technical professional, or product champion.

• 1+ years of experience in authoring or reviewing regulatory filings or similar documentation.

• 1+ years of experience supporting non-conformance investigations, including authoring, reviewing, and defending critical product-impacting non-conformances.

• Experience in project management to support product development.

• Knowledge of quality, compliance, and regulatory requirements for protein and small molecule products.

• Familiarity with analytical techniques used for quality control of protein molecules.

• Understanding of drug substance and drug product development and manufacturing processes.

• Strong leadership and management capabilities.

• General knowledge of cGMP and regulatory filing practices, regulations, and trends related to pharmaceuticals manufacturing and testing.

• Previous experience working within a cross-functional team in a matrix environment.

• Excellent written and verbal communication skills, including facilitation and presentation abilities.

🏝️ Benefits

• Comprehensive employee benefits package, featuring a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.

• Opportunities for career development.

• Financial plans allowing for savings towards retirement or other objectives.

• Support for work/life balance.