Sr Manager QA - Quality Validation & Technical Services

Regulatory Jobs; Holly Springs (NC); On-site; USD 144,000 - 195,000; Full time

Job summary

Amgen is seeking a SR Manager QA – Quality Validation & Technical Services to lead the quality oversight of facility design, qualification, and validation efforts for a new plant and equipment. You will partner across Manufacturing, Facilities, Engineering, and QA to ensure cGMP compliance and timely project milestones.

The role requires strong leadership, regulatory knowledge, and the ability to drive continuous improvement in quality systems, documentation, and risk-based decision making in a

Qualifications

• Bachelor’s degree in science/engineering with QA exposure.
• Experience leading quality teams and cross-functional projects.
• Strong knowledge of cGMP, regulatory trends, and quality systems.

Responsibilities

• Lead quality oversight of design, installation, commissioning and qualification.
• Collaborate with Manufacturing, Facilities & Engineering and others.
• Provide coaching on cGMP processes, documents, records and QC systems.
• Direct quality review and approval of documents for commissioning timelines.
• Represent the quality unit during audits and inspections.

Skills

Leadership

Regulatory knowledge

Quality systems

Communication skills

Risk-based decisions

Education

Bachelor's degree in science/engineering

Master’s degree

Doctorate degree

Job description

Career Category

Quality

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

SR MANAGER QA – QUALITY VALIDATION & TECHNICAL SERVICES

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead activities associated with quality oversight of the design, installation, commissioning & qualification and process qualification of the new facility and equipment. You will collaborate cross-functionally through all stages (construction, facility start-up, operational readiness, operations) to ensure project timelines and landmarks are met. You will lend quality expertise and guidance to strategic and tactical decisions, ensuring both efficiency and compliance in business and operational processes. This includes partnership with Manufacturing, Facilities & Engineering and other support functions providing coaching, guidance and direction on cGMP processes, procedures, protocols, assays, documents, records, quality systems, and compliance aspects.

• Ensure the design of the facilities and equipment, materials, organization, processes, procedures and products stay in sync with cGMP requirements and other applicable regulations.
• Provide quality and compliance expertise and agree on execution strategies related to the design, installation, commissioning & qualification and process qualification of the new facility, equipment, and information systems.
• Directly support and provide leadership for quality review and approval of documents to support facility commissioning and qualification, according to project timelines.
• Ensure the Quality unit provides review, approval and tracking of cGMP processes, procedures, protocols, assays, documents and records including but not limited to Work Orders, Deviations, CAPA's, and Change Controls.
• Ensures that all activities & related documentation for facilities, equipment, materials and processes align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
• Identify and drive implementation of continuous improvement opportunities.
• Collaborate cross functionally and across the Amgen Enterprise/Network to ensure the Quality Management System processes are implemented, maintained and carried out in accordance with established procedures and applicable regulations.
• Build and manage a strong team of Quality professionals that will partner effectively and provide quality oversight for the current and new facilities in the future.
• Ensures deviations from established procedures are investigated and documented per procedures
• Represent the quality unit during audits and inspections as needed.

What we expect of you

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

Basic Qualifications:

• High school diploma / GED and 12 years Quality and/or Operations experience OR
• Associate’s degree and 10 years of Quality and/or Operations experience OR
• Bachelor’s degree and 8 years of Quality and/or Operations experience OR
• Master’s degree and 6 years of Quality and/or Operations experience OR
• Doctorate degree and 2 years of Quality and/or Operations experience
  In addition to meeting at least one of the above requirements, you must have a minimum of 2 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• 2+ years of management experience at a senior quality level.
• Experience in (or strong understanding of) biologics drug substance operations.
• Strong understanding of regulatory requirements and trends, and industry standards.
• Ability to provide sound quality guidance and make data-driven, risk-based, decisions.
• Excellent written and verbal communication skills, with ability to communicate effectively with all levels in the organization.
• Strong leadership capabilities, including ability to develop, coach, empower, and retain staff.
• Ability to effectively collaborate and partner to solve problems, drive improvement, and meet site goals.
• Previous experience in quality oversight of commissioning, qualification, and validation.

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

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Salary Range

144,021.45USD -194,852.55USD