Astellas Pharma
QA Document Control Specialist
Astellas Pharma, Sanford, North Carolina, United States, 27330
QA Document Control 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. 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. The Role The QA Specialist, Document Control will provide day-to-day support to ensure a compliant Document Control program is effectively maintained. This role will have a responsibility for reviewing and identifying opportunities to proactively assure compliance to all applicable internal, domestic, and international quality regulations. This role is the first point of contact for ensuring activities required to implement effective procedures, documents and records to support a cGxP-compliant Document Control program for AGT biological products are carried out to completion. Responsibilities include ensuring adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. Responsibilities Provide daily support of GMP Document Control tasks including but not limited to review of documents for adherence to local and global requirements, controlled print issuance and reconciliation, archive records indexing/management, etc. 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. Provide support to Manufacturing, Facilities, Supply Chain, and other supporting function authors and reviewers/approvers to ensure compliant documents/records. Assist in the implementation of global systems for Document Control program, including implementation and release of future changes. Build relationships with key counterparts and stakeholders across campuses to establish aligned QA Document Control program and related processes that meet both regulatory guidance and company policies. Assist Document Control senior level colleagues in partnering with area leadership to develop and provide instruction for site-level training curricula program to authors, reviewers/approvers of GxP documentation/records. 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 documentation programs. Performs other duties as assigned.
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. 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. The Role The QA Specialist, Document Control will provide day-to-day support to ensure a compliant Document Control program is effectively maintained. This role will have a responsibility for reviewing and identifying opportunities to proactively assure compliance to all applicable internal, domestic, and international quality regulations. This role is the first point of contact for ensuring activities required to implement effective procedures, documents and records to support a cGxP-compliant Document Control program for AGT biological products are carried out to completion. Responsibilities include ensuring adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. Responsibilities Provide daily support of GMP Document Control tasks including but not limited to review of documents for adherence to local and global requirements, controlled print issuance and reconciliation, archive records indexing/management, etc. 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. Provide support to Manufacturing, Facilities, Supply Chain, and other supporting function authors and reviewers/approvers to ensure compliant documents/records. Assist in the implementation of global systems for Document Control program, including implementation and release of future changes. Build relationships with key counterparts and stakeholders across campuses to establish aligned QA Document Control program and related processes that meet both regulatory guidance and company policies. Assist Document Control senior level colleagues in partnering with area leadership to develop and provide instruction for site-level training curricula program to authors, reviewers/approvers of GxP documentation/records. 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 documentation programs. Performs other duties as assigned.