Senior Manager Quality (Technical and Incoming QA)

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.

SENIOR MANAGER QUALITY (TECHNICAL AND INCOMING QA)

At Amgen Breda, medicines are labelled, assembled, stored and shipped worldwide. More than 1,000 colleagues from 38 nationalities work across supply chain, manufacturing, marketing, sales and clinical research. Candidates must live in the Netherlands or commute to Breda.

What you will do

In this key role you will lead the Technical Quality and Incoming Quality teams. Their main responsibilities include managing independent oversight of commissioning, qualification and validation (CQV), computerized system validation, packaging qualification, and the inspection and release of commercial/ clinical packaging materials and products for manufacturing. You will help ensure that facilities, equipment, systems, materials, processes and records meet Amgen requirements and applicable GMP, GDP and other regulatory expectations.

Key accountabilities

Lead and develop  the Technical Quality and Incoming Quality teams. Empower them to continuously deliver on their priorities and objectives by optimizing the capability, capacity, structure and work environment. Apply proactive talent management, succession planning, development and performance management.

Ensure Quality Management System (QMS) is implemented, maintained and effective for Quality Risk Management, Facilities & Equipment Design and Maintenance and Validation.

Provide independent Quality oversight ofs commissioning, qualification and validation (CQV) activities, for facility, equipment and packaging configurations as applicable.

Oversee computerized system validation and data-integrity controls for systems in scope..Ensure commercial and clinical packaging materials, devices and products intended for manufacturing are inspected, sampled, dispositioned and released in line with approved procedures, specifications, sampling plans and regulatory requirements.

Oversee the investigation and escalation of incoming-material deviations. Coordinate supplier-related Quality issues with Supplier Quality and Procurement.

Guide Manufacturing, Warehouse, Supply Chain, Engineering, Technology, Validation and other operational partners on Quality decisions, balancing compliance, patient protection and supply continuity.

Define and track meaningful Quality and performance metrics, report trends and risks, and lead sustainable improvement actions.

Prepare for and lead regulatory inspections, and participate in internal, supplier and partner audits. Drive timely, robust responses and follow-through on observations within scope.

Work with Corporate and network Quality colleagues to share learning, harmonize practices and implement new regulatory expectations.

As a member of the ABR Quality Management Team, contribute to setting and implementing the local Site Quality strategy and goals, and support the ABR Quality team in meeting its priorities. Provide broader Quality leadership cover when needed.

Leadership and decision-making scope

Translate the Quality strategy into clear functional objectives, priorities and resourcing plans, and communicate them to the team and stakeholders.

Set the approach to day-to-day functional operations in line with Amgen policies and Quality leadership guidance.

Be accountable for functional delivery and performance through managers, Quality professionals and technical specialists.

Influence site practices and cross-functional decisions that affect product quality, compliance, patient safety and supply continuity.

Manage functional budgets, resource forecasts, project priorities and operational performance.

 

 

What we expect of you

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

Minimum qualifications

Education and knowledge

Master's degree in Pharmacy, Life Sciences, Engineering or another relevant scientific discipline, or an equivalent combination of education and experience.

Strong knowledge of EU GMP and applicable global regulatory requirements, with the ability to apply regulations and Quality standards in routine and complex situations. GDP and medical-device requirements are an advantage where relevant to site activities.

Strong knowledge of Quality systems, including deviations, CAPA, change control, risk management, audits and inspection management.

Strong knowledge of qualification and validation principles, including computerized system validation and data-integrity expectations.

Fluent written and spoken English.

 

Experience

At least 10 years of progressively responsible Quality Assurance experience in the pharmaceutical, biotechnology or medical-device industry.

At least 5 years of people-leadership or supervisory experience.

Demonstrated experience in at least one relevant area: CQV, computerized system validation, packaging qualification, combination products, incoming-material Quality, Supplier Quality.

 

Core competencies

Sound judgment, proven ability to make timely, high-quality decisions, problem-solving.

Inspire, empower, lead, coach and develop others.

Communicates clearly and effectively, verbally and in writing. Ability to adapt your communication style to the audience.

Build effective networks, collaborate with and influence people across functions and organizational levels to deliver value for patients, staff and shareholders.

Take ownership, deliver results and continuously seek opportunities to improve the performance of yourself, your team, and the way of working.

Manage complexity, balance competing priorities and adapt as priorities shift while upholding Quality standards.

 

Preferred qualifications

Experience in packaging operations or combination products.

Experience with automated inspection; material sampling and release; supplier-management interfaces; and regulatory-authority interactions or inspection support.

Working knowledge of regulatory and Quality considerations for AI-enabled systems in GMP environments, including risk assessment, validation, data integrity, human oversight and lifecycle governance.

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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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.

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