1+ months

Manager, Quality Sytems and Operations Support

Hedgesville, WV 25427
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**Role Description**

Our Quality Operations Mission is "to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives."

Being part of Quality Operations, SCES Quality is responsible for the Quality management of approximately 150 contract manufacturers, packagers, and supply partners globally that support Pfizer Biopharmaceuticals Group.

**The Manager QS&OS is accountable for a variety of Quality Systems and Operational Support activities.**

**This is an independent position operating and interacting with high levels of management both at contract manufacturers and within Pfizer. In this role the colleague operates as point of contact for driving the Quality Systems and Operational support activities and will spend a significant period of time developing relationships, independently negotiating, developing and communicating Pfizer regulatory requirements with contract manufacturers. The QS&OS Manager will provide regulatory and complaint expertise for Classic VSOT's. In this role the colleague will need to make decisions that may require developing new options to resolve complex problems as well as making decisions guided by policies in non-standard situations. The colleague also need to operate independently in ambiguous situations within department. The QS&OS Manager will have significant interactions with many internal business and manufacturing organizations (e.g., ES, GRA, GTE ) and will lead virtually based cross functional teams.**

**The Manager will be responsible for regulatory change management activities as a Site Compliance Network Member (SCNM) and management of routine product complaints for the Drug Products and Drug Substances (APIs) manufactured by Contract manufacturers which supply** Innovative Medicine Business.


**Initiate, review and approve regulatory changes through PDM for changes initiated by or impacting managed Contract manufacturers.**

**Provide support for the closure of the deficiency letters and CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.**

**Serve as the main point of contact for the Global Chemistry, Manufacturing and Controls (GCMC) department or Local Regulatory Affairs in the Pfizer Country Offices (for Single market products) for the various regulatory activities involving** SCES Quality **managed Contract manufacturers.**

**As the Regulatory Compliance and Product Complaint Expert, participate in Virtual Site Operating Teams (VSOT) (or similar) meetings for** SCES Quality **managed Contract manufacturers and if needed, participate in Site Quality visits at the Contract manufacturers.**

**Manage routine Customer Quality complaints for commercial Drug Products in PCOM and work in collaboration with the** SCES Quality - **Contractor Quality Lead for ensuring that the investigation reports are appropriate and acceptable. Ensure timely closure of complaints and alerting the appropriate colleagues as per our procedure and Standard Work guidance.**

**Support and Perform Lot Endorsement for Biotech products in collaboration with other functions.**

**Provides guidance to and/or lead projects. Manages own time to meet objectives; forecasts and plans resources for projects**


+ **Min. BA/BS in Science, Engineering, Pharmaceutical Sciences or related technical discipline**

+ **Min. 8 years of experience in GXP setting and/or Regulatory Affairs role (or 4 years with Master degree)**

+ **At least 4 years of Product Quality Assurance experience in a GMP environment**

+ **Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as PDM, QTS Trackwise, Documentum platforms**

+ **Good command of English language and multi-lingual is a benefit**

+ **Shows strong negotiation skills and is diplomatic in communication with internal and external customers**

+ **Strong verbal and written communication including presentation skills**

+ **Able to report remotely and deliver work independently**

+ **Show strong negotiation skills and customer focus**

+ **Is diplomatic in communication with internal and external customers**

+ **Demonstrated personal leadership to manage cross functional project**

+ **Demonstrate ability to prioritize work, manage multiple projects, act and work independently and to report items as required to Team Leader**

+ **Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor**

+ **Takes initiatives and is proactive, persistent**

+ **Supervisory experience desirable**

+ **Up to 10% travel required**

+ **Has a broad GMP and technical know-how to handle emerging issues**

+ **Developing ability to resolve conflicts**

+ **Has excellent organization skills**

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

Quality Assurance and Control
Posted: 2020-12-09 Expires: 2021-03-11
Sponsored by:
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Manager, Quality Sytems and Operations Support

Hedgesville, WV 25427

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