Specialist, Quality Assurance

About Astellas Gene Therapies

Astellas Gene Therapies is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases. We are leveraging our AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown. Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. Astellas Gene Therapies is a focused, experienced and passionate team driven to improve the lives of patients.

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)

The Role

Quality Assurance for Quality Control (QA for QC) will be primarily responsible for the implementation, execution, and assessment of quality systems, procedures, and records to support compliant laboratory 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 Quality Control, Validation, Document/Data Management, and other GxP supporting functions to ensure compliance. This is accomplished by direct collaboration and oversight of Quality Control activities and the review/audit of data and reports as specified by Standard Operating Procedures.

The Specialist, Quality Assurance for Quality Control will typically report to the Manager, Quality Assurance. 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.

This position will be located in Sanford, North Carolina.

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.

Provide QA oversight for the qualification of laboratory equipment and systems.

Provide QA oversight for the qualification, validation, and transfer of analytical methods.

Provide QA review and authorization of laboratory testing data.

Review and approve laboratory investigations.

Act as QA representative and approver for deviation investigations including Out of Specification (OOS) and Out of Trend (OOT) testing results.

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.

Review and approve CMMS records related to QC equipment.

Define, track, and report quality metrics.

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

Required Qualifications

B.S. degree in Biological/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

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 with internal or external auditing

Experience with rare/orphan diseases and/or gene therapy products

Experience in startup environment

Knowledge of existing and emerging regulations, standards, or guidance documents related to AAV gene therapy production

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-LK1

Category Development QA

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

EOE including Disability/Protected Veterans