【AstraZeneca】【JOPS】Site Quality Lead, Senior Director Quality

AstraZeneca GmbH; Boston (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

AstraZeneca GmbH is seeking a Quality Head in Boston to lead key functions ensuring compliance with global standards. This senior role requires expertise in pharmaceutical quality and strong leadership abilities, particularly within cross-functional teams, while fostering talent development and managing relationships with regulatory agencies.

Qualifications

• Fluent in Japanese and English.
• Extensive experience in the Japanese market cultures.
• Demonstrated ability to attract and develop talent.

Responsibilities

• Leads the Quality function ensuring compliance and effectiveness of the quality management system.
• Oversees training for resources on GMP/GDP obligations.
• Collaborates with stakeholders and regulatory bodies.

Skills

Project Management

Change Management

Interpersonal Skills

Problem Solving

Negotiation Skills

Education

Bachelor’s degree in Pharmaceutical Quality or Regulatory Roles

Job description

• Leads the Quality function to maximize its contribution to business objectives, profitability, and return on investment. May contribute directly to broader AstraZeneca objectives.
• Ensures roles, responsibilities, and reporting lines are clearly defined to maintain a functionally independent quality unit.
• Ensures resources are sufficiently trained with adequate product and process knowledge for GMP/GDP obligations, and supports ongoing professional development.
• Oversees the effectiveness of the quality management system, product quality, and GMP/GDP compliance through management reviews and continuous improvement initiatives.
• Ensures understanding and effective implementation of all applicable external regulations, AstraZeneca Quality Management System, and Code of Ethics across the business area.
• Provides technical oversight for quality and GMP/GDP compliance approaches within the operations business area.
• Promotes professional development within the organization to maintain qualified resources and a strong succession pipeline for the site quality function and broader network.
• Ensures AstraZeneca's involvement and influence in key external organizations and interactions with government agencies overseeing pharmaceutical development, manufacturing, and quality systems in Japan.
• Manages the site’s management review process and ensures management focus on quality and compliance issues affecting Japan Operations.
• Leads the quality aspects of change programs and projects, aligning with the Global Quality strategy.
• Develops relationships with external regulatory bodies and quality networks to enhance efficiency and compliance.
• Collaborates with business and quality colleagues to foster professional development and effective performance management.

【Experience / Mandatory】

- Experience working within cross-functional and global teams.
- Proven track record with regulatory health authorities, stakeholders, government bodies, and industry associations.
- Experience managing significant risks and making robust judgments in high-pressure situations.
- Skilled in change management, budgeting, and project management.
- Demonstrated ability to attract, develop talent, and build capability in leadership roles.
- Extensive experience and understanding of Japanese market cultures.
- Familiarity with Japanese regulations.

【Nice to Have】

- Experience living and working outside Japan.
- Experience in complex manufacturing or supply site environments.
- Experience in GQP roles.

【Languages / Skills / Knowledge / Education】

- Fluent in Japanese and English.
- Ability to set priorities, manage resources, and lead projects in a global/regional context.
- Bachelor’s degree with substantial relevant experience in pharmaceutical quality, manufacturing, or regulatory roles.

【Nice to Have】

- Ability to represent AstraZeneca externally and engage with industry associations.
- Strong problem-solving, conflict resolution, and team leadership skills.
- Knowledge of AstraZeneca policies, procedures, and guidelines.
- Excellent communication, negotiation, and interpersonal skills.