QA Manager

QA Manager

Roles & Responsibilities

• Team Leadership & Management:

  Oversee a team of approximately 6 staff members, ensuring their activities and priorities are managed in a compliant and structured manner. You will conduct goal setting, performance reviews, and compensation planning to align with organizational goals. You'll also ensure that all team members are appropriately qualified and trained.

• Quality System Management:

  Develop, implement, and maintain quality records in compliance with

  GMP

  practices and regulatory requirements. You will be responsible for preparing, reviewing, and approving

  SOPs

  and other

  GMP/GDP

  documentation.

• Process Improvement:

  Continuously improve processes to enhance efficiency and quality by applying lean principles and automation. You'll also develop, monitor, and report metrics to senior management to assess team performance.

• Collaboration:

  Work cross-functionally with various Amgen teams and stakeholders to ensure a seamless transition of tasks and continuity across groups. You will also collaborate with external contract manufacturing organizations.

Qualifications

• A Doctorate degree, a Master's degree with 4-6 years of experience, a Bachelor's degree with 6-8 years of experience, or a Diploma with 10-12 years of experience in quality management systems or a related field.
• Proven experience managing staff in a

  GXP

  environment.
• A minimum of 6 years of experience working in a

  cGMP

  manufacturing environment, with a strong understanding of regulatory requirements and expectations.
• Experience in investigations, project management, and trending and analysis is a plus.
• Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing is a plus.

Soft Skills

• Leadership:

  A proven team leader with the ability to inspire and positively impact others.

• Problem-Solving:

  Excellent analytical and troubleshooting skills to develop thorough and practical solutions.

• Communication:

  Strong verbal and written communication skills, including the ability to present effectively to senior management.

• Collaboration:

  A team-oriented mindset with the ability to work effectively with global, virtual teams and a desire to partner with both internal and external stakeholders.

• Initiative:

  A high degree of initiative and self-motivation, with the ability to successfully manage multiple priorities.