Click or tap here to enter text.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 Role:** The Senior Specialist, QC Systems Support will be responsible for defining requirements, implementation and maintenance for QC support processes and systems including sample and data management (including stability study management and contract lab coordination), as well as investigations, change controls and document revisions. This role will also define, implement and maintain the departmental training program. This role will work closely with the multiple QC groups including Quality Assurance and Manufacturing. This roles primary function will be to support QC investigations and support other operations in QC. **Responsibilities:** + Define, implement and maintain quality control laboratories processes and systems including sample and data management, stability study management and contract lab shipment/testing coordination + Leads laboratory investigations for events and OOS results; evaluates and approves the best CAPA for root cause to eliminate repeat events + Oversees the QC change control process and document revision process; ensures that the integrity and accuracy of all laboratory documents/processes are maintained; must assess overall document/process compliance with protocols, SOPs, company policies, and applicable regulations + Coordination of the QC departmental training program + Manage external sample turnaround times, receipt of data and creation of data packets; ensure samples are packaged and shipped to contract testing laboratories, including completion of required paperwork and receipt of summary reports/results + Collaborate with multiple QC groups to continuously improve programs (e.g., transition from paper-based systems to electronic systems) + Ensure lab compliance with applicable cGMP regulations and SOPs, and support both internal and external audits; Assists in the preparation and review of CMC regulatory submissions + Collect and report, track and maintain metrics for QC systems/equipment and QC users. + Proactively identifies, takes remedial action, and/or seeks advice when a project, team, department, or network goal/deliverable is off schedule + Provide guidance and training to junior colleagues **Quantitative Dimensions:** The QC Specialist IV, QC Systems Support will be responsible for defining requirements, implementation and maintenance of Quality Control lab processes and systems including sample and data management, as well as processing QC requests/actions for investigations, change controls and document revisions. **Organizational Context:** The QC Systems Support, QC Specialist IV will typically report to the Lead, Quality Control Systems Support. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization. **Required Qualifications:** + S. degree in biological sciences, cell biology, chemistry, or related field with 6+ years or M.S. degree with 4+ years of relevant experience in working with laboratory/quality systems + Prior hands-on experience with a variety of laboratory/quality systems/processes such as sample management, data management, stability management, investigations, change controls, document control and/or training. + Experience with electronic systems such as Master Control or other EDMS (Electronic Data Management System), Veeva and/or TrackWise. + Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment, strong knowledge of GMP, SOPs and quality control processes, and strong knowledge of quality systems and regulatory requirements + Good to excellent technical writing skills and verbal communication skills + Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion with a focus on quality and attention to details + Displays strong investigative skills and makes significant independent contributions to the development/improvement/trouble shooting of methodology including new technologies + Highly self-motivated and goal oriented + Will support and demonstrate quality standards to ensure data of highest quality + Works closely with team and other functional key stakeholders on the Astellas AGT Technical Operations team to execute work and will be expected to perform other duties and/or special projects as assigned **Preferred Qualifications:** + Experience and knowledge with utilization of LIMS + Experience managing a business system (e.g., stability or CAPA system) from the QC perspective + Experience serving as a change agent and driving continuous improvement and automation across QC + Expertise with the investigations quality system and able to independently handle complex investigations and determine associated CAPA with no guidance **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._ **\#LI-KT1** Category Sandford TC Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans