Career CategoryQuality
Job DescriptionQA ManagerWhat you will doLet's do this. Let's change the world. In this vital role you will oversee the daily operations of the quality assurance team, ensuring that the company's products meet established quality standards. They implement and manage QA systems, coordinate audits, and lead initiatives to address and prevent quality issues.
Responsibilities:
- Partner with our colleagues in manufacturing, supply chain, facilities and engineering and automation to maintain our strong culture of quality and safety and ensuring the facility operates successfully, efficiently, compliantly, and safely.
- Provide quality oversight of the manufacturing facility including manufacturing operations, testing, inspection and utilities.
- Lead the quality assurance team with a focus on strategic direction, staff development, and maintaining a high-performance culture.
- Champion quality initiatives and collaborate with cross-functional teams to drive and deliver continuous improvement projects.
- Process optimization - assess and optimize quality processes to enhance efficiency and effectiveness
- Ensure compliance with cGMP practices and regulatory requirements.
- Provide leadership and support during both internal/external audits and inspections and audits. Will directly interact with regulatory agencies during on-site inspections.
- Develop and manage training programs to ensure team competencies and understanding of cGMP requirements.
- Manage quality-related issues effectively, ensuring solutions are implemented to prevent recurrence.
- Evaluate team performance and provide coaching to support career growth and professional development.
- Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations.
- Provides quality expertise and guidance to operational staff and within cross functional Amgen teams.
- Represent the Quality function and provide quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals.
- Flexibility to cover different shifts as required by the 24/7 facility production schedule. This role could support a day or swing shift schedule, including partial weekend coverage as part of the standard shift structure.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.
Basic Qualifications:- Doctorate degree OR
- Master's degree and 3 years of quality experience OR
- Bachelor's degree and 5 years of quality experience OR
- Associate's degree and 10 years of quality experience OR
- High school diploma / GED and 12 years of quality experience
In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:- Bachelor's Degree in Science
- 5 plus years of aseptic processing experience in QA or Manufacturing
- Regulatory Knowledge: Thorough understanding of cGMP, FDA, EMA, and other regulatory requirements.
- Leadership Skills: Strong leadership and people management skills, with the ability to mentor, develop, and motivate a team.
- Analytical Thinking: Excellent analytical and problem-solving skills, with the ability to make sound decisions based on data.
- Communication Skills: Exceptional communication and interpersonal skills, with the proficiency to interact effectively with all levels of the organization and external partners.
- Attention to Detail: High attention to detail and the ability to manage multiple priorities in a fast-paced environment.
- Continuous Improvement: A commitment to continuous improvement and staying current with the latest industry trends and best practices.
- Aseptic Knowledge: Expertise in aseptic processing and cleanroom operations, with a focus on maintaining sterility and preventing contamination.
- Risk Management: Ability to identify, assess, and mitigate risks to product quality and patient safety.
- Operational Excellence: Experience in supporting manufacturing operations, with a focus on efficiency, compliance, and safety.
- Collaboration: Proven ability to develop strong partnerships and work collaboratively with cross-functional teams, including manufacturing and Facilities & Engineering (F&E) colleagues.
- Audit and Inspection Readiness: Experience in preparing for and leading audits and inspections by regulatory authorities.
What you can expect from usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible
Salary Range118,235.00USD -159,965.00 USD
