Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.

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: https://www.astellas.com/en

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

Our Values:

• Be BOLD (Find a Way)

• Care Deeply - for our patients, each other and our work

• #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

Reporting to the Manager, Quality Assurance (QA) the QA Validation Engineer for CSV will be primarily responsible for the implementation, execution, and assessment of quality systems, procedures, and records to support compliant GMP operations. Responsibilities include ensuring adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. This position works closely with Computer System Validation (CSV), Site Validation, Engineering, Manufacturing, Facilities, Document/Data Management, and other GxP supporting functions to ensure compliant computerized systems are deployed and maintained. This is accomplished by direct collaboration and oversight of CSV activities and the review/audit of data and reports as specified by Standard Operating Procedures. This position will be based in our Sanford, NC facility.

Primary Responsibilities

• Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance to SOPs and relevant Good Regulated Practice (GxP) requirements.

• Partner with the enterprise CSV and site Validation team to define validation strategies as it relates site specific systems including those used for automation and enterprise computerized systems.

• Perform review and approval of commissioning and qualification documents for equipment, systems, and processes following established standards and templates, including but not limited to the following:

• Validation plans including project plans and validation status lists.

• Specification documentation: e.g., URS, DS, FRS.

• Risk Assessments and Impact Assessments.

• Qualification / validation protocols, e.g., IQ/OQ/PQ and Summary Reports.

• Protocol Discrepancies and associated corrective actions

• Engineering Change Record

• Standard Operating Procedures related to validation execution.

• Ensure the quality of CSV documentation that is generated to support a cGMP regulated biologics manufacturing environment, e.g. Right the First Time Focus.

• Author, review, and approve controlled documents for the Quality organization and other GMP functional areas including SOP's, specifications, protocols, and reports

• Author, review, and approve Quality System records including Deviation, CAPA, and Change records including associated causal and impact assessments

• Facilitate risk assessment, cross functional team discussions in support of major/critical deviation investigations and change controls

• Define, track, and report quality metrics

• Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections as needed

About you

Must Have/Required

• QA Validation Engineer (CSV)- B.S. degree inBiological/Physical/Chemical sciences, engineering, or equivalent focus of study and 5-8+ years of experience or M.S. degree and 3-5+ years of experience in a QA function in a biologics manufacturing facility

• Strong knowledge of risk-based approach to commissioning, qualification and validation activities in a biotech manufacturing environment.

• Strong understanding of FDA, EMA, local regulations and guidelines, Good Engineering Practices, ICH guidelines, and industry best practices.

• Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects

• Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others

• Excellent problem-solving skills and experience with root cause investigations and CAPA determination

• Strong computer skills including MS Office (Word, Excel)

• Off hours coverage and flexibility may be required

• Physical Requirements: Able to frequently lift, carry or move, and position objects weighing up to 30 pounds. Able to bend, stoop and crouch to inspect materials or place labels. Consistently able to move about to coordinate work

• Models our Core Values: Be Bold, Care Deeply, #GetStuffDone - is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

May Have/Preferred

• Experience reviewing and approving commissioning and qualification documentation related to CSV

• Experience implementing enterprise LIMS systems

• Experience implementing software systems used in laboratory settings

• Experience in a small company and high growth, fast-paced environment

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

• 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

Category Quality Assurance

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

EOE including Disability/Protected Veterans