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Specialist, QA Validation

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. For more information, please visit our website: www.astellasgenetherapies.com.

The Role

The Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation.

Responsibilities

+ Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance with local and global quality standards, regulatory requirements, and industry guidance.

+ Provide QA review and approval for commissioning/qualification/validation documents.

+ Provide QA review and approval of qualification and validation deviations and discrepancies and support investigation and corrective actions.

+ Work collaboratively with other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP principles including the underlying rationale of those principles.

+ Author, review and approved controlled documents for the Quality organization and other GMP functional areas including SOPs, specifications, protocols, and reports.

+ 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 3-5+ years of experience or M.S. degree and 1-3+ 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 environment.

+ Experience with qualification/validation of process equipment, analytical instruments, clean utilities, automation, sterile filling, and clean facilities.

+ 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.

+ Advanced computer skills.

+ Off hours coverage and flexibility may be required.

Preferred Qualifications

+ Experience with computer verification/validation.

+ Experience working in a clinical and commercial manufacturing environment (Drug Substance and Drug Product).

+ Experience working in a sterile fill/finish facility.

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