Roles & Responsibilities:
- Oversee a team of approx. 6 staff, ensuring their activities and priorities are managed in a compliant and structured manner.
- Ensure team members are appropriately qualified and trained to perform needed activities per company procedures.
- Conduct goal setting, performance reviews, and compensation planning to align with organizational goals.
- Develop, implement, and maintain quality records in compliance with industry standards, GMP practices, and regulatory requirements.
- Continuously improve processes to enhance efficiency and quality, by applying lean principles and automation.
- Develop, monitor and report metrics to senior management to assess the health of the team's performance.
- Develop solutions that are thorough, practical, and consistent with functional objectives.
- Work cross functionally with various Amgen teams and stakeholders to ensure seamless transition of tasks and continuity across groups.
- Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
- This role may require working in shifts or extended hours within the same shift to support global time zones.
What we expect of you
Basic Qualifications and Experience:
- Doctorate degree OR
- Master's degree with 4 to 6 years of experience in quality management systems or a related field OR
- Bachelor's degree with 6 to 8 years of experience in quality management systems or a related field OR
- Diploma with 10 to 12 years of experience in quality management systems or a related field.
- Experience managing staff in a GXP environment
Functional Skills:
Must-Have Skills:
- Working foundation in quality assurance roles and proven team leader.
- Minimum of 6 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.
- Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them
Good-to-Have Skills:
- Experience in investigations, project management and trending and analysis
- Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing.
- Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).
- Proven experience in designing and/or improving processes at conceptual level
- Desire to partner with internal and external stakeholders across teams
- Understanding of industry requirements/expectations of a robust Quality Management System and documentation.
Soft Skills:
- Excellent analytical and troubleshooting skills.
- Strong verbal and written communication skills
- Ability to work effectively with global, virtual teams
- High degree of initiative and self-motivation.
- Ability to manage multiple priorities successfully.
- Team-oriented, with a focus on achieving team goals
- Strong presentation and public speaking skills.
