Sr. Manager, QA Systems (Change Management)

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com.

The Sr. Manager, Quality Assurance Systems, will be to provide Quality oversight to Astellas Gene Therapies (AGT) Quality Management Systems (QMS), own the Quality oversight of the transition of AGT QMS applications to Astellas QMS applications, own the Change Management program, inspection readiness of QMS, QA oversight of QMS improvement projects for AGT, and other aspects related to QA oversight required to support GMP manufacturing operations. This position will be located in Sanford, NC reporting directly to the Site Head of Quality.

Job Responsibilities

• Establish and maintain expert knowledge on quality systems/regulatory requirements in accordance with applicable FDA Regulations, EudraLex and ICH Guidance, as well as other applicable regulatory requirements applicable to the organization, continuously review guidance publications for industry and upcoming changes to regulations for QMS.•Effectively communicate initial implementation and/or changes of QMS requirements to functional groups ensuring understanding and implementation of required actions, and overall compliance.• Facilitate cross functional team discussions or assessments in support of major/critical QMS transition/changes/implementations.•Own the Change Management (CM) Program including CM policies/procedure and continuous improvement for AGT.•Own the transition of AGT Quality Management Systems to Astellas Quality Management Systems.•Collaborate with process owners that utilize QMS to develop value-added metrics that meet regulatory requirements in accordance with applicable FDA Regulations, EudraLex and ICH Guidance, as well as other applicable regulatory requirements applicable to the organization.•Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained. Examines use of QMS to create efficiencies in practices.• Effectively drives for results and effectively network and communicate cross-functionally, cross-site.•Implement and improve programs in alignment with corporate directives and best practices.•Interact with corporate auditing and compliance functions to ensure global alignment of Quality Systems.•Routinely suggests new techniques/aids in areas of technical expertise; strong ability to operationalize create ideas proposed; frequently engages new ideas or ways of doing things and influences creative thinking.•Participate as System SME during internal/external inspections, including corrective actions are implemented to improve compliance.•Drives continuous improvement of the AGT QMS through new QMR content that includes communication and escalation of Quality System health.•Develops and provides effective communication of QMS health statistics to leadership. •Design and actively participates in special assignments on various project teams and work streams as determined by QA management.

Required Qualifications

• Bachelor’s degree in a scientific or technical discipline, and 10+ years of pharmaceutical experience in biotechnology or pharmaceutical industry in quality or quality systems in people or team leadership roles, 8+ years of experience with MS and 6+ years of experience with PhD, or equivalent combination of education and experience.•4+ years related management experience (people/processes or systems), including consistently creating opportunities for colleagues to improve their knowledge and skills needed in their current job; showing courage in delivering tough feedback focused on improving colleague performance; works with direct reports to identify and facilitate career growth opportunities.•Expert level knowledge of regulatory requirements (US and International) related to GMP manufacturing quality systems. • Experience building, integrating, and maintaining Quality Management Systems, QMS, with corporate systems.•Expertise in Change Management required•Proven QA experience including successful implementation and oversight of Quality Management Systems, inspection readiness and health authority inspection management in a cGMP biologics manufacturing environment.•Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.•Regularly interacts with senior management or executive levels on matters concerning several functional areas.•Strong analytical, communication, and negotiation skills as well as sound judgment, with the ability to work effectively with others.•Some travel (up to 5%) may be required.•Advanced computer skills with working knowledge of MS office, Word, Excel, Access, Adobe Acrobat, Box etc.•Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.

Preferred

• Experience in clinical and commercial GMP environments.•Experience working with Quality systems in support of early, late-stage development, and commercial programs.•Experience with Veeva Quality programs and TrackWise.•Self-motivated with ability to plan, organize and prioritize multiple tasks and able to perform under pressure to meet production deadlines.•Ability to deal with ambiguity, creative and pragmatic approach to problem solving.•Developing and implementing compliance related metrics for Quality Management Review and site compliance tracking.

Working Conditions

• This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs• This is an on-site role working in a cGMP regulated manufacturing facility• On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%)

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

• 401(k) match and annual company contribution

• Company paid life insurance

• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

• Long Term Incentive Plan for eligible positions

• Referral bonus program

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

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Category Product QA

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans