25 days old

Gene Therapy Quality Operations Upstream Manager

Pfizer
Sanford, NC 27330
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**ROLE SUMMARY**

The position will be responsible for performing the following Quality Assurance (QA) responsibilities: batch disposition, investigation approval, complaints handling, Biological Product Deviation Reports (BPDR) issuance and Annual Product Record Reviews (APRR). In addition, the position will be responsible for day-to-day- oversight of Upstream/Downstream Stage 2 Gene Therapy (GTx) Quality Operations Teams and ensuring alignment with the Stage 1 Gene Therapy Quality Operations and Vaccines Quality Operations roles.



As Stage 2 is currently in the design phase, the successful candidate will be responsible for developing processes and procedures to perform these responsibilities. This will require working collaboratively with cross-functional groups in Stage 2, at the Sanford site and across the Pfizer network.



This is a first shift Job, occasional shift work may be required to support manufacturing operations.



**ROLE RESPONSIBILITIES**



Serves as the primary contacts for Stage 2 GTx Quality Operations day-to-day matters. Responsible for escalating significant concerns to Management.



Leads Continuous Improvement initiatives to create compliant, efficient processes for Quality Operations in Stage 2. This includes developing and maintaining standard work, visual management and problem solving using DMAIC methodology.



Interfaces with the Stage 1 Quality Operations team and Sanford Vaccines Quality Operations team to ensure consistent approaches and sharing of best practices.



Responsible for performing the following Stage 2 Gene Therapy QA responsibilities: batch disposition, manufacturing floor support, investigation approval, complaints handling, Biological Product Deviation Reports (BPDR) issuance, and Annual Product Record Review (APRR); and overseeing junior level team members executing the aforementioned responsibilities.



Responsible for knowing, understanding, role modeling, and ensuring others follow Pfizer's values and culture.



Supports initiatives that contribute to building and strengthening the quality culture within the Gene Therapy Facility. Practices and encourages quality cultural behaviors within both Quality and business lines.



Acts as SME for department to support site audits/inspections.



Interfaces with other parts of the organization such as Global Quality Operations groups and Pfizer Research and development groups.



**BASIC QUALIFICATIONS**

5-8 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field

3-5 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field

Previous experience with a startup facility and developing Quality Operations processes is beneficial.

Experience with Drug Substance and Drug Product commercial manufacturing preferred.



+ **Last Date to Apply for Job: 3/31/2020**

+ Eligible for Relocation Package

+ Eligible for Employee Referral Bonus

+ \#LI-PFE



**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.



**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.



Quality Assurance and Control
Posted: 2020-03-05 Expires: 2020-04-18

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Gene Therapy Quality Operations Upstream Manager

Pfizer
Sanford, NC 27330

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