Sr Mgr QA Systems, Business & Compliance

Career Category

Quality

Job Description

Reporting to the Quality Assurance Director, this role is responsible for key aspects of quality systems, compliance and auditing functions at the ADL site.  Responsibilities will also extend to managing key quality-related business and metric reporting including elements of quality business management at the ADL facility.

The role will have primary responsibility and oversight for the development, implementation and maintenance of key quality and compliance related procedures and processes, including but not limited to; internal auditing/self-inspection program, Regulatory and Partner Inspection Management, Change Control, Deviation/CAPA, Quality Risk Management, Document Management and Quality Management review processes.  This role ensures that quality processes are effectively implemented, revised and optimised to ensure a continuous drive to improve product and process quality at the site.

Other responsibilities will include: Interfacing with Senior Management and Regulatory Inspectors, Corporate Quality and other network functions. 

Working within the overall quality function at ADL and reporting to the Quality Assurance Director, this role has high visibility and will involve key skills in data management, presentation and direct involvement with key improvement and Operational Excellence initiatives.  This position requires demonstration of strong management/leadership skills with advance communication and analytical skills, with a proven track record in regulatory inspections.

The Senior Manager will be responsible for ensuring that SOP’s and policies are created and maintained in line with Regulatory and Amgen Standards and will be responsible for leading a team of QA Specialists which may change in line with business requirements.

Key Responsibilities Include;

• Oversee and maintain site inspection readiness program and Quality Management review processes.
• Host inspections (self-inspection and regulatory/corporate inspections).
• Develop key metrics for department to afford visibility of the health of our quality processes and liaise with Leadership for business related metrics and improvement opportunities.
• Manage inspection outcomes, including inspection response compilation and tracking.
• Oversee and implement Quality Agreements relating to area of responsibility
• Challenge current procedures and practices to afford optimisation and further development of existing quality standards and overall compliance.
• Keep abreast of regulatory initiatives and new guidance/requirements
• Lead and mentor Quality Assurance team to challenge the status quo and realise improvement opportunities
• Collaborate with key internal and external stakeholders including manufacturing, regulatory affairs, Engineering, Development, Supply Chain, Automation and IS teams.
• Other duties as assigned by the Quality Assurance Director

Leadership Responsibilities

• Mentor, coach, challenge and develop Quality Systems & Compliance Team whilst serving as a role model and mentor.
• Individual goal setting and performance reviews.
• Ensure compliance with all legal and business requirements, Amgen policies and practices.
• Identification and communication of risk in area of responsibility.
• Effective utilisation of resources through employee development, performance management, succession planning and rewards, recognition practices in area of responsibility.

Basic Qualifications

Doctorate degree and 2 years of directly related experience
OR
Master’s degree and 6 years of directly related experience
OR
Bachelor’s degree and 8 years of directly related experience
OR
Associate’s degree and 10 years of directly related experience

5 years of supervisory experience

Preferred Qualifications

• Background in Biological or Sterile manufacturing 
• Well-rounded experience in quality assurance including deviation management, validation, change control, Quality Risk Management and auditing disciplines.
• Proven track record in regulatory inspection hosting and general engagement.
• Good technical skills and excellent interpersonal skills including strong verbal and written communication skills.
• Degree educated with a minimum of 5 years supervisory experience
• Strong communication, relationship building, leadership and mentoring skills. Proven ability to manage and deliver results in a highly fluid, interactive matrix environment
• Project Management and Data Analytics

.