Sr Manager QA - QVTS

Amgen • Holly Springs, NC

17h • $144,021 - $194,853

About The Position

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

Requirements

• 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
• 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

Nice To Haves

• 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.

Responsibilities

• Lead activities associated with quality oversight of the design, installation, commissioning & qualification and process qualification of the new facility and equipment.
• Collaborate cross-functionally through all stages (construction, facility start-up, operational readiness, operations) to ensure project timelines and landmarks are met.
• Lend quality expertise and guidance to strategic and tactical decisions, ensuring both efficiency and compliance in business and operational processes.
• Partner 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager