Manager QA - Nights

Initial Therapeutics, Inc.; West Greenwich (RI); On-site; USD 140,000 - 180,000; Full time

Job summary

Amgen seeks a Manager QA - Nights to lead the Quality Assurance team on the night shift, ensuring GMP manufacturing compliance and effective change control.

You will hire, train, and develop QA staff, review procedures, and coordinate with cross-functional groups to drive investigations, CAPA, and audits while maintaining timely product releases and patient safety.

Qualifications

• 12 years of Quality or Manufacturing experience OR higher degrees with less experience
• Experience directly managing people and/or leadership experience leading teams, projects, or resources
• Experience in GMP Manufacturing and change control processes

Responsibilities

• Lead and manage the Night shift Quality Assurance teams; schedule 6pm–2:30am
• Review and approve operational procedures, product manufacturing procedures, and change controls
• Lead investigations and plant/site audits; drive CAPA and incident triage
• Partner with management to resolve issues, allocate resources, and drive departmental improvements
• Support GMP manufacturing and ensure compliant, efficient operations

Skills

Leadership experience

Quality assurance

Manufacturing experience

People management

Education

High school diploma / GED

Associate degree

Bachelor's degree

Master's degree

Doctorate degree

Tools

CAPA systems

Investigations

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Manager QA - Nights

What you will do

Lets do this. Lets change the world. In this vital role you will hire, train, develop, and manage Quality Assurance professionals to successfully deliver on role to support GMP Manufacturing and to manage change in an effective, efficient and compliant manner.

This individual will be responsible for overseeing our Night shift Quality Assurance teams, and the schedule will be M-F 6pm - 2:30am.

Additional Responsibilities:

• Independently determine approach to managing daily operations; guided by general policies and management guidance

• Develop or contribute to the development of procedures and standards by which others will operate.

• Interpret and execute standards and procedures directly affecting work activities

• Develops and communicates goals and objectives to staff and key partners

• Monitor goal performance and coordinate action for improvement of shift and overall PQA performance by championing department OPEX efforts. Assist project teams in establishing priorities, project timelines and in securing resources.

• Actively represent Quality Assurance on incident triage teams or support efforts by providing guidance and/or technical leadership

• Partner with internal personnel at various management levels to resolve issues, establish direction, obtain resources, and drive change

• Reviewing and approving operational procedures and product manufacturing procedures, approving process validation protocols and reports for manufacturing processes, and approving environmental characterization reports and change control documents.

• Approving non-conformances, representing QA on project teams and approving change-over completion controls.

• Leading investigations, as well as leading plant and site audits.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a team leader with these qualifications.

Basic Qualifications

• High school diploma / GED and 12 years of Quality or Manufacturing experience OR

• Associates degree and 10 years of Quality or Manufacturing experience OR

• Bachelors degree or and 5 years of Quality or Manufacturing experience OR

• Masters degree and 3 years of Quality or Manufacturing experience OR

• Doctorate degree

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

• Bachelors Degree in Life Sciences, Engineering or related field

• 6+ years of quality assurance or combination of quality and manufacturing experience in the biotechnology/pharmaceutical industry

• 2+ years of supervisory/management experience

• Experience in areas of manufacturing, investigations, CAPA, product release, validation and/or change control

• Experience in regulations, standards and guidelines that apply to biotech manufacturing in a multi-product environment

• Ability to develop meaningful team and staff goals, manage performance and coach and develop staff

• Ability to manage to established timelines and deliver results to meet or exceed department and company goals and objectives.

• Thorough knowledge of monoclonal antibody manufacturing or ability to apply previous biotech manufacturing knowledge to understand manufacturing deviations

• Ability to communicate clearly, facilitate discussions and present to audiences at all levels of a site organization

• Decisive and independent risk-based decision-making ability on the floor to support manufacturing needs

• Ability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant manufacturing

What you can expect of us

As 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, well 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.