12 days old

Sr. Manager, Auditor

Pfizer
New York, NY 10007
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**Why Patients Need You**



Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.



**What You Will Achieve**



You will be a member of Pfizer's dedicated and highly effective quality assurance team. You will evaluate and review Pfizer's clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.



As a Senior Manager, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division.



It is your problem solving ability that will make Pfizer ready to achieve new milestones and help patients across the globe.



**How You Will Achieve It**



+ Develop ideas and lead/co-lead complex projects across business units and develop plans to achieve objective.

+ Monitor quality and insure inspection readiness.

+ Work with Supply Chain and Pfizer Global Supply colleagues to develop procedures which increase efficiency and maintain high quality standards.

+ Assist in developing and provide guidance for the implementation of fit-for-purpose and risk based Good Manufacturing Practices {also cGMP} standards for contractor practices and quality oversight.

+ Provide subject matter expertise representing Manufacturing Quality Assurance (MQA) at cross-functional forums and/or projects as endorsed by MQA management.

+ Provide support for global manufacturing sites and Pfizer internal departments (regulatory, operations etc.).

+ Assess compliance of PCO processes, clinical investigator sites, vendors, study activities, pre-clinical research activities, data, and reports and submissions.

+ Support design and delivery of relevant privacy training to local colleagues, deliver training programs in support of site/center requirements and coach site trainers.

+ Drive customer relationships and deliver quality improvement recommendations for stakeholders.

+ Identify and implement continuous improvement initiatives for relevant teams.

+ Incorporate best practices and improvement initiatives shared by CoE (Center of Excellence).

+ Provide clear, direct and timely verbal and written communication to stakeholders.



**Role Summary**



Regulatory Quality Assurance (RQA) is an independent Quality audit function within the Compliance division, accountable to identify risks and non- compliance associated with Pfizer's GxP regulated operations.



The Sr. Manager, Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GxP enterprise processes that span GCP, PV, Regulatory, Medical or are conducted at the Pfizer Country Offices. This role is responsible for GxP Oversight and for assuring the compliance of projects, products and programs with Pfizer Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National



**ROLE** **RESPONSIBILITIES**



+ Independently conduct wide range (non-routine) complex audits (minimal to no oversight - as needed)

+ Execute audit strategy and lead process audits

+ Act as a reviewer of audit reports from outsourced or routine audits

+ Assess audit plans and quality metrics to identify potential areas of risk

+ Actively support regulatory inspections as needed

+ Identify and drive process improvements

+ Deliver awareness sessions with oversight by manager on various GxP topics internally and externally

+ Drive interactions with QA colleagues at other Pfizer locations to ensure consistency in application of QA strategy and to promote standardization of auditing approach within QA

+ Actively engage in discussions to determine impact of changing needs of the regulatory environment

+ Work with RQA colleagues on cross GxP audit plans as required

+ Coach colleagues - lead training for routine and non-routine site and process audits

+ Advise business representatives (e.g. BPOs) on outcomes of complex audits and provides input to process improvement activities



Independently/with minimal supervision demonstrate leadership by providing clients with influence and recommendations to meet changing GxP business needs



**Qualifications**



**Must-Have**



+ Bachelor's Degree

+ 7+ years' experience

+ Experience supporting or leading Quality audits and developing/managing remediation plans

+ Relevant pharmaceutical experience including previous Pharmacovigilance / clinical Quality Assurance experience conducting a broad range of audits

+ Broad knowledge of relevant regulatory current Good Manufacturing Practices {part of GxP} audit frameworks that apply to pharmaceutical operations, its trends and expectations and familiar with other Good Practice concepts and global regulations

+ Strong verbal and written communication including presentation skills

+ Strong project management skills

+ Demonstrates comprehensive working knowledge of business concepts and quality operations

+ Displays critical thinking expertise, with ability to define and implement a strategic approach to audit based on compliance and business knowledge

+ Strong use of quality and auditing frameworks and application

+ Routinely suggests new audit techniques and approaches, and operationalizes to improve the audit system

+ Ability to identify trends within data and apply insights to make recommendations and decisions

+ Ability to bring recommendations to stakeholders for discussion and input

+ Actively leads and progresses efforts to deliver operational improvements

+ Exhibits good project management capabilities

+ Has domain expertise in 2 or more technical areas

+ Ability to work with ambiguity and adapt plan when needed

+ Experience evaluating and understanding quality standards or their application

+ Uses and interprets qualitative/quantitative data to drive decision making, operationalize recommendations and understand potential impact to other areas of the business



**Nice-to-Have**



+ Master's degree

+ Experience in the pharmaceutical industry with preference for a diverse background encompassing operational risk and compliance management not only within QO but also experience in Operations, Validation, QC or other technical discipline

+ Technical and practical knowledge of a variety of dosage forms

+ Has 8+ years of experience (2 levels; operations and auditing required)

+ Lead audit teams (2-6 ppl per team)

+ Demonstrates stakeholder and conflict management (communications, relationship management)

+ Negotiates needs & acquires feedback on audit outcome

+ Preferred experience in audits with a background in PV, Process, Digital or other related quality areas

+ Expertise in 1+ major areas (PV, PCO, Digital); and 2+ minor specializations OR 2+ major and 1+ minor

+ Ability to function autonomously in a matrix model and in a team environment

+ Provides training/mentorship to other auditors or SMEs



**Other Job Details:**



+ **Last Date to Apply for Job: June 15, 2021**

+ Additional Location Information: New York City; Peapack, NJ; USA - Remote

+ Eligible for Employee Referral Bonus



**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



\#LI-PFE
Posted: 2021-06-04 Expires: 2021-07-17
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Sr. Manager, Auditor

Pfizer
New York, NY 10007

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