QA Data Integrity Specialist

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 QA Specialist, Data Integrity will be responsible for the execution of the Data Integrity program elements, including but not limited to, compliance gap assessments, collaborating with key stakeholders to ensure all elements of DI are embedded and carried out through established work practices, to ensure compliance with Astellas local/global and regulatory requirements, and participating in related data integrity process improvement initiatives within Astellas Gene Therapies, Sanford NC site. Ensures consistent application of Data Integrity regulations and guidelines to GxP data generated and managed for clinical development and commercial operations across Astellas or Service Providers to ensure compliance with global Astellas standards, policies, and procedures and regulatory requirements. Executes process improvement and supports new technology initiatives for Astellas Gene Therapies. Contributes to the development, implementation, and successful execution of the QA mission, objectives and 3–5-year strategic plan.

Responsibilities

• Execute daily program level responsibilities, including development and implementation of processes and continuous improvements to ensure productivity and alignment with departmental/site/global goals.

• Establish and foster a cGMP quality culture that prepares the site for regulatory pre-approval inspections and eventual licensure for commercial manufacturing.

• Manages and executes assigned process improvement initiatives related to data integrity control processes, and regulatory compliance processes throughout Astellas. Manages multiple assigned projects concurrently.

• Collaborates with key stakeholders and functional area customers across the Astellas organization for process improvement initiatives and to communicate compliance issues to management.

• Provide support to Manufacturing, Facilities, Supply Chain, and other supporting function stakeholders to ensure DI-compliant processes.

• Provide computerized systems validation and implementation oversight, as it relates to DI, to ensure system functionality meets all DI requirements, and/or that remediation and/or mitigation actions are monitored via a Quality System (i.e., TWD eQMS, Change Mgmt., etc.)

• Assist in the implementation of global systems for the Data Integrity program, including implementation and release of future changes.

• Build relationships with key counterparts and stakeholders across campuses to establish aligned QA Data Integrity program and related processes that meet both regulatory guidance and company policies.

• Assist AGT Site DI Lead in partnering with area leadership to develop and provide instruction for site-level training curricula program to ensure DI compliance across all GxP functions (as applicable).

• Participate and represent the company in regulatory (e.g., FDA, EMA, DHHS, etc.) inspections and audit activities conducted by third-party and corporate partners as quality process owner for DI.

• Performs other duties as assigned.

Required Qualifications

• Bachelor’s degree in a related scientific or technical discipline with 4+ years of experience in biotechnology or pharmaceutical industry specifically in the area of QA Data Integrity support and/or operations and/or related quality function in a regulated industry.

• Working knowledge of US and International GMPs, FDA/ICH Guidance, and best practices in a biotech manufacturing and testing environment

• Proven ability and enthusiasm to lead, motivate, inspire, develop, and encourage colleagues.

• Well-organized and detailed oriented professional, with strong verbal and written communication skills.

• Advanced computer skills with working knowledge of MS office such as Word, Excel, and Adobe Acrobat

• Must be self-motivated with ability to handle, organize and prioritize multiple tasks and be able to perform under pressure to meet production deadlines.

• Proven experience with electronic document management system(s) and electronic signatures.

• Proven experience with executing DI assessments, and assurance of gap remediation implementation.

Preferred Qualifications

• Experience in a GMP facility startup, high growth, and fast-paced environment

• Experience working with Quality systems in a commercial-ready gene therapy facility.

• Ability to represent the company to external stakeholders during vendor audits and interacting with regulatory agencies

• Ability to proactively predict and resolve complex problems, think strategically and tactically, and to execute/implement solutions to complex problems.

Working Environment

• This position is based in Astellas Gene Therapies Sanford, NC and will require on-site work in a cGMP regulated manufacturing facility.

• On occasion, this role may travel to other Astellas Gene Therapies 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 BioPharma QA

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

EOE including Disability/Protected Veterans