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New Products Program Manager


Rocky Mount, NC
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Job Details

The **Program Manager, Pfizer CentreOne/New Products** is responsible for coordinating site activities related to the launch of new products. Interfaces with all facets of plant operations to execute program deliverables as defined in technical transfer documents. Position plays a vital communication role for the site in assuring that all stake holders (corporate/site cross functional team members, third party customers, regulatory authorities, suppliers, etc) are versed in advancing the objective forward. Supports the continuous improvement process by providing technical support to various Rocky Mount business units. Assists in preparation of ANDA, NDA, and SNDA submissions and any required registration batches. Responsible for tracking and assisting in the release of products manufactured for the Pfizer CentreOne business and/or generics. This includes review of exception documentation, batch record documentation as deemed necessary and validation documentation. Leads business reviews and participates in quality councils between all parties (customer and corporate Pfizer CentreOne). Also will lead all site activities as it relates to product changes requested by assigned customer(s).

**Role Responsibilities**

Produces registration batches for ANDA, NDA and SNDA submissions.

Supports site during customer audit and during regulatory inspections.

Interface with Partners on routine basis to drive customer centricity and fulfill terms of quality technical agreements and master supply agreements.

Reviews studies, exceptions, and validations for impact to customer's products.

Expedites release of commercial product for customers and Hospira generics.


+ Minimum of 4 years of experience in the pharmaceutical industry.

+ Bachelor's of Science (engineering, science, industrial technology) from an accredited university

+ Minimum of 2 years experience with batch record documentation, product and process specifications, and standard operating procedures.

+ Knowledge of regulations for drug and medical devices.

+ Knowledge and ability to interface with the FDA during inspections that impact area of responsibility.

+ Strong written and verbal communication skills and professionalism. Demonstrated ability to write logically and consistently when preparing protocols and reports.

+ Knowledge of Investigation process.

+ Strong social skills.

+ Strong customer focus.

+ Strong problem solving skills.

+ Strong organizational skills.

+ Proven experience with various computer software applications to track and trend quality metrics.

+ Ability to work and adapt in a fast pace environment.

+ Ability to understand commercial strategies and business applications.

+ Ability to demonstrate behavioral anchors

+ Walks

+ Climbs stairs.

+ Stand up to 1-2 hours.

+ Sit for up to 6-8 hours.

+ Works around moving equipment.

+ Wears specialized protective clothing.

+ Works in hearing conservation area.

+ Uses a computer terminal 6-8 hours/shift ore and Leadership competencies

**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.

**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.

**Other Job Details:**

+ **Last Date to Apply for Job: 1/24/2018**

+ Additional Location Information: Rocky Mount, NC

+ Eligible for Relocation Package

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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