Manager Quality Assurance - PQA

Career Category Quality Job Description HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Live What you will do Does the thought of building an entirely new site from the ground up excite you? Do you love cultivating sustainable systems and high performing teams? If you have a passion execution excellence and want to be a part of Amgen’s mission to serve patients – every patient every time – then check out this exciting new opportunity. Amgen, one of the world’s leading biotechnology companies is investing $550 million to build a new multi-product drug substance biomanufacturing facility in Holly Springs, North Carolina, a biomanufacturing “hub” known for their life sciences industry. The new plant will combine two production formats, traditional stainless steel fed batch and single use technology. This combination of capabilities is an approach that Amgen calls “FleX Batch” manufacturing, which makes the facility more dynamic and efficient, as well as requiring a smaller physical footprint than a traditional plant. Additionally, the plant will integrate innovations to advance digitalization and sustainability, aspiring to embed industry 4.0 capabilities and reduce energy consumption and waste generation to meet Amgen’s plan to be carbon neutral by 2027. Let’s do this. Let’s change the world. Manager Quality Assurance- PQA In this dynamic role you will be the Manager Quality Assurance for the PQA team and will work directly with plant manufacturing and engineering staff during the Amgen North Carolina (ANC) facility startup and transition to on-going bulk drug substance manufacturing, including development, clinical, launch and commercial operations. The Manager Quality Assurance will hire, train, develop, and manage Quality Assurance professionals to successfully deliver on role to support (Good Manufacturing Practices) GMP Manufacturing and to oversee and manage change in an effective, efficient and compliant manner. This includes partnership with Manufacturing, Facilities & Engineering and other support functions providing coaching, guidance and direction in regards to deviations, quality systems and compliance aspects. The initial focus of this role will be on the ANC startup to prepare the new facility for Operational Readiness. *Candidate will be working on site, supporting a shift working schedule, to include late afternoon and nights. Role for Second shift (Example 2pm-10:30pm). Responsibilities: Oversee ANC startup activities for facilities, utilities, equipment, systems and processes with alignment and integration into the Amgen Quality Systems, including: Interview candidates to build the ANC PQA team, Author/review/approve quality documents, related to: Standard Operating Procedures (SOPs), user requirements, risk assessments, training materials, engineering documents, automation documents, commissioning test protocols/reports, environmental & utility qualification protocols/reports, validation protocols/reports, Oversee execution of, and change management related to, the following: factory acceptance, commissioning tests, facility qualifications and validation activities. Manage a team of PQA staff and their daily operations (verify training, schedules, ongoing tasks, prioritization and support needed) Oversee staff/team performance Prioritize and support staff development Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations Participate in Inspection Readiness program activities to ensure facilities, equipment, materials, organization, processes and procedures comply with cGMP practices and other applicable regulations Develop or contribute to the development of procedures and standards by which others will operate Develop and communicate goals and objectives to staff and key partners Monitor goal performance and coordinate action for improvement of team and overall Plant Quality Assurance (PQA) performance by championing department operational excellence and Lean 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 Review and approve operational and product manufacturing procedures, process validation protocols and reports for manufacturing processes, environmental characterization reports and change control documents. Support site audits and inspections. 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, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above * Experience can also include Manufacturing, Operational Excellence, Engineering and/or Data/Information Systems experience Preferred Qualifications Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources Experience and training in CDOCS, Trackwise, Maximo, LIMS, MES Werum and other systems and applications Experience in managing multiple, competing priorities in a fast-paced environment Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate clearly, facilitate discussions and present to audiences at all levels of the organization. a site organization with ability to communicate and collaborate effectively with technical and senior management staff. Experience and systems knowledge in areas of manufacturing investigations, Corrective Actions/Preventative Actions (CAPA), product release, validation and/or change control Ability to develop meaningful team and staff goals, manage performance and coach and undefined Ability to manage timelines and deliver results to meet or exceed department undefined Ability to solve complex problems and evaluate scientific data. Decisive and independent risk-based decision-making ability on the floor to support manufacturing needs. Thrive Some of the vast rewards of working here As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being. Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey. A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com #AmgenNorthCarolina Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. 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, or disability status. . Salary Range 118,235.00USD -159,965.00 USD