6 days old

QA Manager

Pfizer
Andover, MA 01810
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**ROLE SUMMARY**

This position is responsible for quality and compliance oversight of programs in the BioTherapeutics (BTx) portfolio including gene/cell therapies, vaccines, bi-specifics, nanoparticles, and combination products as a Quality project lead. This position will represent Pharm Sci Quality Assurance (PSQA) on early and late stage project teams, inclusive of new and emerging modalities and technologies. The position requires a solid understanding of quality systems and compliance regulations as they relate to the manufacturing, testing, stability, scale-up and development of biologic products including cell banking, cell culture/fermentation, purification, sterile drug product and medical devices for clinical use. Some business travel may be required to other Pfizer locations or external partners.



This position requires identification and appropriate escalation of significant issues and compliance matters through management and compliance channels.



This position may be based at the Andover, MA or St. Louis, MO.



**ROLE RESPONSIBILITIES**



+ Represents PSQA in support of the biologics portfolio. Provides quality leadership and oversight of biologics project teams (early stage Pharm Sci Project Teams and late stage Co-Development Teams), including GMP manufacturing, testing and disposition of GMP materials for use in clinical trials.

+ The candidate will possess strategic and working knowledge of the biologic product life cycle from IND to BLA, including experience with process and method validation and strategy.

+ Provides Quality oversight for project-related investigations and issues and advises on policies and procedures. Contributes to the interpretation of GMPs for functional areas.

+ Supports authoring of Quality Assurance Agreements with Alliance Partners or other established pharmaceutical companies.

+ Communicates with and influences internal and external customers across site and department boundaries to ensure compliant and aligned resolution of project related issues and investigations (i.e., Pharm Sci, PGS, CMOs, etc.).

+ Reviews and approves various GMP documents including batch records, protocols/reports, investigations, change controls, period of use, dosing and administration instructions, product specifications, etc.

+ Advises more junior colleagues on significant or complex issues associated project team oversight, ensuring appropriate resolution and escalation, as required.

+ Performs disposition of materials manufactured by Vendors or PGS for use in clinical trials.

+ Represents PSQA on late stage program strategy, including ICH Stability strategy, BLA strategy, Right First Time, etc.

+ Leads and/or participates on limited duration teams, continuous improvement initiatives and special projects for PSQA and Pharm Sci.

+ May act as a point of contact between Pharm Sci QA and specific PGS biotech site(s). Ensures communication, resolution and alignment regarding quality and compliance matters when clinical trial materials are manufactured and/or tested by PGS.

+ Supports portfolio programs in combination biologic/device platforms. Provides compliance oversight to Medical Device regulations and QSRs.

+ Establishes him/herself as an SME for cGMP related quality and compliance and acts as a resource to project teams and direct reports.



**BASIC QUALIFICATIONS**



+ Educational Requirements BS/MS - minimum of 8 years technical / scientific / Biopharmaceutical experience. PhD - minimum 5 years technical / scientific / pharmaceutical experience relevant work experience.



+ Based upon education, candidate should possess a minimum of 8-10 years of Biopharma industry experience that includes a broad understanding of Biopharmaceutical Sciences processes. In addition, extensive knowledge of global GMP and regulatory requirements as related to the drug development process is required. Experience in Quality Assurance possessing strong quality culture is desirable. Team player with strong interpersonal, organizational, and communications skills are a must. Additionally, the candidate must be self-motivated, engaged and able to perform moderately complex tasks independently.



**PREFERRED QUALIFICATIONS**



+ Strong biologics experience

+ Gene/cell therapy experience

+ Vaccines experience



**PHYSICAL/MENTAL REQUIREMENTS**



+ Mental agility to handle a broad scope of different types of quality assurance work (i.e., reviewing documentation, communicating one on one or with larger groups, motivating team, influencing direct and indirect reports). Ability to independently problem-solve and make recommendations for solutions.

+ Role is primarily office-based: sitting, standing, walking and bending. This is inclusive of leading/participating in WebEx.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



Standard 40-hour work week.

Some travel required.



**OTHER INFORMATION**



+ Eligible for Employee referral



**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.



+ **Last Date to Apply for Job: 08.27.2019**

+ Eligible for Employee Referral Bonus



N (Other) (United States of America)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Posted: 2019-08-14 Expires: 2019-09-14

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QA Manager

Pfizer
Andover, MA 01810

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