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AstraZeneca · 16 hours ago

Associate Director, Quality

Boston, MA

Full-time

Hybrid

Lead/Staff, Director/Executive

$128K/yr - $192K/yr

10+ years exp

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates as precision medicines. The Associate Director, Quality is responsible for overseeing quality assurance processes related to suppliers, developing quality strategies, conducting audits, and collaborating with cross-functional teams to ensure products meet quality standards.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Develop and implement a comprehensive supplier quality strategy aligned with organizational goals

Evaluate and select suppliers based on quality performance, capabilities, and risk assessments

Establish and maintain strong relationships with key suppliers to drive quality improvements

Oversee supplier audits and assessments, ensuring adherence to quality standards and regulations

Develop and implement quality metrics to monitor supplier performance

Collaborate with suppliers and internal teams to identify areas for quality improvement

Drive initiatives such as root cause analysis and corrective action plans for quality issues

Work closely with procurement, engineering, and manufacturing teams to align supplier quality goals with operational needs

Facilitate training and knowledge sharing regarding quality standards and processes

Prepare quality reports for senior management, highlighting trends and areas of concern

Qualification

Supplier Quality ManagementQuality Management SystemsRadiopharmaceuticals ExperienceQuality Tools Six SigmaQuality Tools LeanData Analysis ToolsAnalytical SkillsSupplier Risk ManagementProblem-Solving SkillsCommunication SkillsInterpersonal SkillsLeadership Skills

Required

Bachelor's degree in Engineering, Quality Assurance, Supply Chain Management, or a related field

Minimum of 10-12 years of experience in supplier quality management

Strong knowledge of quality management systems (e.g., ICHQ10) and quality tools (e.g., Six Sigma, Lean)

Excellent analytical, problem-solving, and decision-making skills

Strong communication and interpersonal skills, with the ability to work collaboratively across functions

Demonstrated ability to effectively lead professional staff and teams

Familiarity with supplier risk management and assessment methodologies

Proficiency in quality management software and data analysis tools

Approximately 20-30% business travel required to external Contract Development Manufacturing Organization (CDMO) / Business Partner sites, or to attend professional development training seminars – as needed / directed

Preferred

Master's degree

Prior experience with radiopharmaceuticals

Phase 1/Phase 2 supplier quality management experience in a Biotech/Pharma setting

Benefits

Qualified retirement programs

Paid time off (i.e., vacation, holiday, and leaves)

Health, dental, and vision coverage in accordance with the terms of the applicable plans

Short-term incentive bonus opportunity

Equity-based long-term incentive program (salaried roles)

Retirement contribution (hourly roles)

Commission payment eligibility (sales roles)

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees

https://www.astrazeneca.com

H1B Sponsorship

AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (2)

2020 (11)