Specialist, Quality Assurance

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 Specialist, 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. This role will ensure adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. The Specialist, QA for QC will work 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.

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, 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; Quality System records including Deviation, CAPA, and Change Management records including associated causal and impact assessments; 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 qualification and validation activities in a Biotech Quality Control environment.

• Strong understanding of FDA, EMA, local regulations and guidelines, 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.

• Off hours coverage and flexibility may be required.

• Ability to support and demonstrate Quality standards to ensure data of the highest quality.

Preferred Qualifications:

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

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

• Experience working in a Laboratory Information Management system.

Working Environment:

• This position is based at 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.

#LI-TD

Category BioPharma QA

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

EOE including Disability/Protected Veterans