Senior Quality Assurance Manager

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

📋 Description

• Provide effective quality oversight for suppliers in accordance with global regulations, establishing quality requirements and monitoring supplier performance.

• Track and assign quality status and, when necessary, determine remediation actions and additional oversight needed, including technical site visits.

• Maintain essential quality performance indicators for the suppliers under your responsibility.

• Review and authorize quality documentation including Quality Agreements, supplier investigations, deviations, supplier change notifications, change controls, CAPAs, and CAPA-EVs.

• Oversee the completion of supplier audits.

• Serve as the primary contact for Amgen sites to address concerns and support projects related to secondary packaging materials and suppliers.

• Act as Amgen's representative during product-specific regulatory inspections and/or Notified Body audits at supplier sites.

• Identify and mitigate risks at supplier sites, escalating issues to management as necessary.

• Facilitate the onboarding and offboarding of suppliers and/or manufacturing locations as required.

• Lead departmental improvement initiatives focused on continuous improvement and automation.

⛳️ Requirements

• Doctorate degree with 2 years of Quality and Compliance experience OR Master’s degree with 4 years of Quality and Compliance experience OR Bachelor’s degree with 6 years of Quality and Compliance experience OR Associate’s degree with 10 years of Quality and Compliance experience OR High school diploma/GED with 12 years of Quality and Compliance experience.

• Educational background in Life Sciences.

• In-depth technical knowledge and experience in operations within the pharmaceutical or GMP-regulated industry.

• Relevant experience in Drug Product and Finished Drug Product operations.

• Over 5 years of experience in overseeing the quality of suppliers.

• Strong problem-solving skills and experience in root-cause analysis.

• A solid continuous improvement mindset.

• Extensive knowledge of compliance, quality, and regulatory standards, complemented by critical thinking skills and an inquisitive, end-to-end perspective.

• Excellent communication skills with proficiency in English and the ability to collaborate across functions.

• Strong report writing and presentation skills.

• Experience in driving decision-making using DAI principles.

• Understanding of industry requirements and expectations of a Quality Management System (QMS).

• Proficient with data and Artificial Intelligence tools.

• Familiarity with applicable manufacturing and testing processes (such as API, Drug Substance, Drug Product, Packaging, and Device manufacturing processes).

🏝️ Benefits

• A comprehensive employee benefits package, which includes a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program, or, for field sales representatives, a sales-based incentive plan.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.